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. 2023 Jul;30(7):4097-4108.
doi: 10.1245/s10434-023-13364-z. Epub 2023 Apr 11.

Breast-Conserving Surgery Margin Guidance Using Micro-Computed Tomography: Challenges When Imaging Radiodense Resection Specimens

Samuel S Streeter  1   2 , Rebecca A Zuurbier  3   4 , Roberta M diFlorio-Alexander  3   4 , Mark T Hansberry  3 , Benjamin W Maloney  5 , Brian W Pogue  5   4   6 , Wendy A Wells  4   7 , Keith D Paulsen  5   4 , Richard J Barth Jr  8   9
Affiliations

Breast-Conserving Surgery Margin Guidance Using Micro-Computed Tomography: Challenges When Imaging Radiodense Resection Specimens

Samuel S Streeter et al. Ann Surg Oncol. 2023 Jul.

Abstract

Background: Breast-conserving surgery (BCS) is an integral component of early-stage breast cancer treatment, but costly reexcision procedures are common due to the high prevalence of cancer-positive margins on primary resections. A need exists to develop and evaluate improved methods of margin assessment to detect positive margins intraoperatively.

Methods: A prospective trial was conducted through which micro-computed tomography (micro-CT) with radiological interpretation by three independent readers was evaluated for BCS margin assessment. Results were compared to standard-of-care intraoperative margin assessment (i.e., specimen palpation and radiography [abbreviated SIA]) for detecting cancer-positive margins.

Results: Six hundred margins from 100 patients were analyzed. Twenty-one margins in 14 patients were pathologically positive. On analysis at the specimen-level, SIA yielded a sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 42.9%, 76.7%, 23.1%, and 89.2%, respectively. SIA correctly identified six of 14 margin-positive cases with a 23.5% false positive rate (FPR). Micro-CT readers achieved sensitivity, specificity, PPV, and NPV ranges of 35.7-50.0%, 55.8-68.6%, 15.6-15.8%, and 86.8-87.3%, respectively. Micro-CT readers correctly identified five to seven of 14 margin-positive cases with an FPR range of 31.4-44.2%. If micro-CT scanning had been combined with SIA, up to three additional margin-positive specimens would have been identified.

Discussion: Micro-CT identified a similar proportion of margin-positive cases as standard specimen palpation and radiography, but due to difficulty distinguishing between radiodense fibroglandular tissue and cancer, resulted in a higher proportion of false positive margin assessments.

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Conflict of interest statement

DISCLOSURES Samuel S. Streeter, Benjamin W. Maloney, Keith D. Paulsen, and Brian W. Pogue have a patent pending (US Application No.: 17/076,788) related to this study. Richard J. Barth Jr. is Co-Founder and CMO of CairnSurgical, Inc. Keith D. Paulsen is Co-Founder of CairnSurgical, Inc. Brian W. Pogue is President and Co-Founder of DoseOptics, LLC. Authors in their roles in the medical industry did not in any way impact this study. The remaining authors have no competing interests.

Figures

FIG. 1
FIG. 1
Enrolled patients
FIG. 2
FIG. 2
Representative specimens (each row) with intertwined tumor and fibroglandular tissues making radiological interpretation difficult. The columns from left to right (red, green, then yellow) show intersecting transverse, coronal, and sagittal planes in each scan. The specimen in row (a) was confirmed to have four positive margins by histopathology (red arrows), while all other specimens in rows (b)–(f) had only pathologically negative margins. IDC invasive ductal carcinoma; DCIS ductal carcinoma in situ; ILC invasive lobular carcinoma
FIG. 3
FIG. 3
Representative specimens (each row) with beam-hardening artifacts from the surgical guidewire (a–c) and surgical clip (a–b) that impacted radiological interpretation of specific margins (yellow arrows). The columns from left to right (red, green, then yellow) show intersecting transverse, coronal, and sagittal planes in each scan. Only the cranial margin of the specimen in row (a) was confirmed to be positive by histopathology, while all margins of the specimens in rows (b) and (c) were confirmed to be pathologically negative. IDC invasive ductal carcinoma; DCIS ductal carcinoma in situ
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