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Breast Imaging |
1 From the Departments of Radiology (D.J.M., P.M.P.), Pathology (R.N.E., R.D.N.), and Surgery (J.C.W.), Greenwich Hospital, 5 Perryridge Rd, Greenwich, CT 06830. Received July 13, 1999; revision requested September 1; revision received July 14, 2000; accepted July 28. Address correspondence to D.J.M. (e-mail: davidm@greenhosp.org).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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MATERIALS AND METHODS: Three hundred seventy-six consecutive patients (with 383 lesions) were referred for stereotactic breast biopsy. Two hundred forty-seven lesions were carbon marked when the need for surgery was likely. Patients who underwent marking were followed up for the results of surgery or mammography performed at our institution. Specimen sizes obtained by using the carbon mark were compared with sizes of consecutive biopsy specimens obtained after hook-wire localization.
RESULTS: Carbon marking was well tolerated in all cases. All 132 surgeries performed at the authors’ institution were successful in removing the marked target. Specimen sizes compared favorably with sizes of comparison hook-wire localization specimens. All 68 lesions followed mammographically revealed no changes that were attributable to the use of carbon. Two minor complications were observed. Two small cancers were completely removed at needle biopsy.
CONCLUSION: Carbon marking is safe and effective for marking the biopsy site and needle track created by stereotactic large-core-needle biopsy of the breast. Marking eliminates the need for postprocedural needle localization. It remains effective when small lesions have been completely removed. This technique should be considered in properly selected cases by those performing large-core-needle biopsy of the breast.
Index terms: Biopsies, technology, 00.1261, 00.1267 • Breast, biopsy, 00.1261 • Breast neoplasms, diagnosis, 00.31, 00.32 • Stereotaxis, 00.1267
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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In 1989, Azavedo and colleagues (11) described stereotactic fine-needle aspiration of mammographically detected breast abnormalities. In this series, carbon marking was performed when a high level of mammographic suspicion was present prior to fine-needle aspiration. Stereotactic large-core-needle biopsy was described by Parker et al (12,13) in 1990 and 1991. In these series, excisional biopsy was performed immediately after stereotactic needle biopsy by using a wire that was placed at the end of the procedure. Investigators in other controlled series reported the use of a wire (14) or a wire and methylene blue (15) for immediate postprocedural surgical guidance. In subsequent published series, separate needle localizations have been performed at a later date, as necessitated by the results of initial stereotactic biopsy.
The need for surgery after some stereotactic needle procedures is well known (11,15,16). Large-core-needle biopsy of the breast generally leaves no mammographically detectable abnormalities (17,18). In addition, the risk associated with the "complete" removal of small abnormalities has been recognized (19) and is increased following 11-gauge vacuum-assisted biopsy (18,20). Such cases may still require wide excision of the biopsy cavity (17); for this reason, placement of a permanent mark after large-core-needle biopsy is of increasing importance. The use of titanium and stainless steel clips (21,22) and embolization microcoils (23) has been advocated in selected cases by some investigators.
In early 1991 we were prepared to begin our own trial of stereotactic needle biopsy for the evaluation of mammographically detected breast abnormalities. We were concerned about potential problems associated with a separate postprocedural localization after stereotactic large-core-needle biopsy. We undertook this study to investigate the use of a sterile aqueous suspension of carbon to mark the biopsy site and needle track in patients who undergo large-core-needle stereotactic breast biopsy.
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MATERIALS AND METHODS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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The method of carbon marking has been previously described (7). We used a sterilized 4% weight/weight aqueous suspension of activated charcoal powder USP (Mallinckrodt Baker, Phillipsburg, NJ), injected through an 18-gauge needle with a stylet (Discal; Becton-Dickinson, Franklin Lakes, NJ) by using a 10-mL eccentric-tip syringe (Becton-Dickinson), with the eccentric tip kept dependent in the needle holder (Fig 1). The volume injected varied early in the series but was later limited to less than 0.3 mL injected slowly as the needle was withdrawn. A tattooing (to and fro) motion of the needle along the entire length of the biopsy track was then performed until carbon staining at the point of skin entry was observed.
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Marking was deemed necessary if (a) the mammographic lesion was considered highly suspicious for cancer, (b) there was a high degree of suspicion on the basis of immediate cytologic examination results, (c) specimen insufficiency was suspected on the basis of the absence of calcifications on core biopsy specimen radiographs (24), (d) we suspected that the lesion might be removed in its entirety during the procedure, or (e) the patient was in a study group of 25 during the initial validation of these new techniques at our own institution.
The reasons for performing surgery included cancer (11), atypical ductal hyperplasia (25), discordant mammographic and needle biopsy findings (16), or the patient’s participation in the initial study group of 25. All surgeons on the hospital’s medical staff participated in the surgical procedures required.
The initial study group also underwent coaxial placement of a wire through the 18-gauge needle. In the first 14 lesions marked, substantial z-axis errors in wire placement were noted in two, and wires were dislodged from the track during transportation to surgery in two. All surgeons indicated a strong preference for the carbon mark, so wires were abandoned.
All needle biopsy procedure reports were reviewed for a history of carbon marking. Those reports with a history of carbon marking were checked against pathology and radiology databases for a history of further activity after carbon marking. Stereotactic biopsy records were also reviewed for a history of reported complications after biopsy. Those patients with markings who subsequently underwent surgery at other institutions or without follow-up at our institution were excluded from further analysis. The imaging- and pathology-related items were reviewed (by P.M.P. and R.N.E., respectively).
In the group that was followed up, all needle biopsy histology reports were reviewed. The group was divided into three subgroups that underwent (a) surgery for cancer treatment, (b) excisional biopsy for further diagnosis, or (c) mammographic follow-up.
In the subgroups that underwent further surgery, visualization of the skin mark and dissection along the carbon trail were used to guide the surgeon to the lesion. Histopathology reports were checked for the presence of the targeted lesion within the specimen, the presence of carbon within the specimen in proximity (<5 mm) to the targeted lesion, and the dimensions of the specimen. Specimen slides were reviewed when these data were not recorded in the original histopathology report. Specific note was made of those cases in which the lesion had been completely removed at the previous needle biopsy, on the basis of histologic examination results. Radiographs obtained immediately after stereotactic biopsy were not used to assess complete removal.
In the mammographic follow-up subgroup, all patients had benign results of initial biopsy. The reports of subsequent mammography were reviewed for any abnormality that differed from that for which biopsy was originally performed.
All biopsy specimens obtained after standard hook-wire localization during 1999 and all lumpectomy specimens obtained during 1999 were reviewed to compare their dimensions. The volume of the tissue samples was estimated by multiplying their length, width, and height.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Of 132 specimens on which surgery was performed, 130 contained the targeted lesion within 5 mm of the carbon track. Two small cancers were not found within generous lumpectomy specimens that contained the carbon and needle track; this was indicative of complete removal at initial needle biopsy. Thus, all surgeries were considered successful in removing the carbon-marked target. The time until surgery was 0–83 days after biopsy and carbon marking (mean, 14.5 days ± 14.1 [SD]).
In 132 surgeries, 88 lesions were preoperatively diagnosed as cancers. Of these, 14 were removed at mastectomy or modified radical mastectomy. No specimen dimensions could be obtained in one ductal carcinoma in situ. Thus, specimen dimensions were available in 73 lesions. Volume estimates were 4.5–1,872.0 mL, with a mean of 216.53 mL ± 225.00 (95% CI: 156.00, 278.00). Forty-one consecutive lumpectomies performed without carbon marking during 1999 revealed a specimen volume range of 17–1,380 mL, with a mean of 212.4 mL ± 237.0 (95% CI: 137.0, 287.0).
Forty-four lesions required surgery for further diagnosis. No specimen dimensions could be obtained in one. In the 43 lesions with recorded specimen dimensions, volume estimates were 3.75–216.00 mL, with a mean of 44.50 mL ± 46.50 (95% CI: 30.00, 53.00). One hundred four consecutive specimens obtained after standard hook-wire localization during 1999 revealed a volume range of 1.76–143.00 mL, with a mean of 27.50 mL ± 23.30 (95% CI: 23.00, 32.00).
Sixty-eight lesions were followed up with mammography. The length of follow-up was 4–91 months (mean, 46.7 months ± 24.3). No abnormalities attributable to the use of carbon were observed.
A small black mark was visible at the skin entry site in all cases; it probably is permanent (Fig 2). When needed, the carbon trail was used during surgical dissection as a visual guide to the biopsy site. Carbon was identified along the biopsy track in all specimens. Representative specimens are shown in Figures 3 and 4.
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In the early part of the series, complications attributable to the use of carbon were observed in two patients during the immediate postbiopsy period. In the first patient, biopsy had been performed on a lesion close to the chest wall, and surgery was performed on the same day (indication: being in the initial study group of 25). During surgery, it was noted that some carbon had spread deep to the breast and along the chest wall through a puncture in the pectoralis fascia. The excisional biopsy specimen was benign, and the patient was followed up mammographically for 1 year without any subsequent abnormality demonstrated. In the second patient, spontaneous discharge of a small quantity of black liquid from the puncture wound was noted several days after carbon marking and needle biopsy, which had revealed benign histologic findings. This patient was followed up mammographically for 7 years without any subsequent abnormalities demonstrated. After this patient’s presentation, the volume of carbon injected was minimized as described in the Materials and Methods section. Other complications included two hematomas, which were ascribed to the biopsy procedure itself. No other complications were observed in the patients who underwent marking.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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Carbon falls from suspension quickly, so it is important to shake the bottle well before drawing the carbon into the syringe. The dependent orientation of the eccentric tip of the syringe ensures that the highest concentration of carbon within the barrel of the syringe is injected through the needle.
Because the carbon mark is placed immediately after biopsy, the need for separate needle localization is eliminated. It must be recognized that needle localization is not foolproof. Complications (26–29) and a failure rate of 1%–10% in the removal of the targeted abnormality have been reported (2). Furthermore, as we also noted, stereotactic needle localization along the z axis is sometimes inaccurate (14,30,22); this is probably due to breast compression and large-core-needle excursion beyond the target during firing. This makes clip placement variable within the biopsy cavity (20,22). Investigators (31) have documented this problem recently in a series of patients in whom "freehand" localization for cancers "completely" removed during core biopsy was required and inaccurate clip placement had previously occurred.
Carbon, however, marks the entire cavity and needle track, and it is noteworthy that, in this series, all 132 lesions necessitating surgery were successfully removed. In contrast, Svane (7) found that two of 56 carbon-marked lesions were not recovered at the first surgery. We hypothesize that the larger track created during core biopsy reduces resistance to injection and facilitates the dispersion of carbon throughout the entire length of the track. This results in a more continuous trail, which reliably extends through the lesion and thus improves the success rate of carbon marking.
There are drawbacks to all dye techniques, which include carbon marking. Dissection must roughly follow the line of tissue staining. As such, care should be taken to help minimize the length of the dissection by using the shortest approach to the lesion during stereotactic biopsy (7). Another limitation is that the carbon trail is not palpable. Nevertheless, surgeons readily accept carbon marking. Although the use of transillumination has been described (10), it was not performed during our trial. Our surgeons simply review the mammograms with the radiologists, observe the mark on the skin, and then dissect along the carbon trail.
A majority (88 [66.6%]) of the 132 lesions in this trial for which surgery was required had been diagnosed as cancer at initial needle biopsy. As might be expected, no substantive difference in lumpectomy specimens, as compared with specimens in patients who did not undergo carbon marking, was observed. In those 44 lesions (33.3%) in which surgery was required for further diagnosis, a majority were the first 25 in our initial study group. Despite the fact that the 1st 25 lesions were encountered early in our series, it is interesting that little difference (17 mL) was noted in their specimen sizes, as compared with the sizes of a sample of hook-wire–localized excisional biopsy specimens. We continue to perform standard localization in patients who have not undergone prior stereotactic biopsy and carbon marking. We have noted no substantive difference in postsurgical deformities in patients who underwent carbon marking, as compared with those who underwent standard wire localization.
The stability of carbon marking over time is one of its strengths (7,8,10) and makes it especially appropriate after large-core-needle biopsy. Because activated charcoal is particulate and not water soluble, it stays within the track and does not diffuse into surrounding tissue, in contrast with methylene blue. Furthermore, fixation of carbon particles by phagocytosis subsequently occurs and permanently marks the track. This is most often useful in the 1st few days after the procedure but is occasionally valuable much later if circumstances necessitate a longer delay before surgery.
The permanence of the mark may have other interesting implications. Carbon marking may indicate the exact location of the site of initial biopsy in the rare instance of the subsequent development of a serendipitous mammographically occult cancer in proximity to the initial biopsy site (12). For that matter, it is also conceivable that carbon marking might indicate the reason for a missed diagnosis. Although these problems did not occur in the current series, they may have serious medicolegal implications for the physician who performed the initial biopsy.
The problem of complete removal of a small cancer has become better understood in recent years. In this series, carbon worked well as a guide in subsequent surgery in the two (1.5%) of the 132 lesions in which complete removal occurred. It should be noted that, because, in our series, complete removal was noted at histologic examination only, our reported rate is probably lower than that which might be expected if we had relied on mammography for assessment.
Needle seeding (epithelial displacement) of cancer along a biopsy track is rare but has been described in the breast (32). During the process of giving informed consent, patients often express concern about this possibility. Some investigators have suggested removal of the biopsy track in patients in whom cancer has been diagnosed and breast-conserving therapy is desired (32). Carbon marking requires removal of the track, which obviates this issue.
The materials needed for carbon marking are readily available and of negligible cost. The activated charcoal, bacteriostatic water, 10-mL vial, and sterilizing equipment needed are on hand in any hospital pharmacy. Although no charge for the carbon suspension or its instillation was made during the study, we estimate our total costs at $13.70 per patient, which includes the labor required from the pharmacy. This is in direct contrast with the alternatives currently in use. Cost estimates for competing methods must include the cost of the needle and hook-wire assembly and fees for their introduction. The cost of metallic clips or coils also must be considered.
One hundred thirty-two (53%) of the 247 lesions marked were spared from undergoing an additional needle procedure. This number would have been even greater if the mark had been used in those who left our hospital to undergo surgery. Although the mark was never used to guide surgery in 115 (47%) of the 247 lesions marked, the cosmetic abnormality created is minimal and no mammographic abnormalities are demonstrable. When informed consent obtained prior to large-core-needle biopsy includes a full discussion of the possible need for repeat localization, patients quickly grasp the value of this method, as evidenced by the fact that no patient refused carbon marking when given the choice of its use. Furthermore, we have yet to receive a single complaint regarding the small mark visible on the skin.
Some have raised concerns with regard to the use of carbon and stated that it has not yet been approved by the U.S. Food and Drug Administration (FDA) (33). Some detail is justified to clarify this important issue.
The FDA regulates the interstate commerce of drugs and manufacturers’ claims with regard to the effectiveness of their products. The FDA, however, has no role in the regulation of medical practice. It is for this reason, for example, that methylene blue can be used by any physician for breast marking if he so chooses, despite the fact that it has FDA market approval for only one use: the treatment of drug-induced methemoglobinemia via the intravenous route of administration. The fact that the package insert specifically warns against subcutaneous administration does not mean that the "off-label" use of this drug for tissue marking is prohibited.
A full discussion of the medical use of activated charcoal as a gastrointestinal adsorbent is available in any contemporary textbook of pharmacology. It is educational to explore the parallels between the history of the use of activated charcoal to treat toxic ingestion (34) and its current status for breast marking.
The use of activated charcoal to treat toxic ingestion was well researched long before its widespread clinical acceptance in the United States. Despite its proved superiority to other drugs then in use for this purpose, the lack of a commercially available FDA-approved product was an impediment to the dissemination of this technique. Although many physicians vigorously advocated its use, drug manufacturers were reluctant to pursue the FDA approval process for fear of a lack of patent protection and profitability (34).
Prepackaged charcoal is now available for the treatment of toxic ingestion; however, prior to its commercial availability, the compound had to be locally prepared by a pharmacist. Compounding the mixture is messy, and many physicians today are unfamiliar with the use of locally prepared drugs.
The FDA Modernization Act of 1997 (35) clarified the status of compounded drugs in section 503A: If a compound is made locally in limited quantities from either FDA-approved or USP monograph substances and is prescribed for each patient by a physician, it is specifically exempted from the FDA’s new drug regulations.
Carbon is biologically inert and has been used in skin tattoos for centuries (36). Study of the histopathologic specimens in this series and others (10,37) revealed at most only low-grade foreign-body reaction, and no clinical symptoms were noted in patients who had received carbon, including many who were followed up for several years. Carbon has been demonstrated by other investigators (7–10) as safe for breast marking, and the results of the current study confirm their findings. Even india ink (non–USP monograph activated charcoal in colloidal suspension with multiple additives) has been described as safe for tattooing the bowel wall after endoscopic biopsy to provide subsequent guidance for follow-up endoscopy or possible surgery (37). Until someone is motivated to pursue the FDA approval process, tattooing should be considered a described off-label use of this substance.
In conclusion, carbon marking of the biopsy site and needle track after stereotactic large-core-needle biopsy of the breast is safe and effective as a marker for the subsequent surgical removal of residual lesions, the biopsy track, and/or the biopsy cavity. Carbon marking is well tolerated by patients, is quickly performed after needle biopsy, and adds virtually no cost to the procedure. Most important, it eliminates the need for repeat localization when needle biopsy results necessitate further surgery. Carbon marking creates no noticeable mammographic abnormalities, is stable over time, and obviates the implantation of metallic objects in the breast when the complete removal of a small abnormality is considered likely. These features make it ideal as a method for localization after large-core-needle biopsy. Carbon marking should be strongly considered in properly selected cases by those performing large-core-needle biopsy of the breast.
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FOOTNOTES |
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Abbreviation: FDA = Food and Drug Administration
Author contributions: Guarantor of integrity of entire study, D.J.M.; study concepts and design, D.J.M., J.C.W., R.D.N.; definition of intellectual content, D.J.M.; literature research, D.J.M.; clinical studies, D.J.M., R.N.E., R.D.N., J.C.W.; data acquisition, P.M.P., R.N.E.; data analysis, D.J.M., P.M.P., R.N.E.; manuscript preparation and editing, D.J.M.; manuscript review, D.J.M., P.M.P., R.N.E.
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REFERENCES |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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