Magnetic resonance imaging system for intraoperative margin assessment for DCIS and invasive breast cancer using the ClearSight™ system in breast-conserving surgery-Results from a postmarketing study.
Adult
Aged
Breast Neoplasms
/ diagnostic imaging
Carcinoma, Ductal, Breast
/ diagnostic imaging
Carcinoma, Intraductal, Noninfiltrating
/ diagnostic imaging
Female
Humans
Intraoperative Care
Magnetic Resonance Imaging
Margins of Excision
Mastectomy, Segmental
Middle Aged
Product Surveillance, Postmarketing
Prospective Studies
Sensitivity and Specificity
diffusion weighted
lumpectomy
re-excision rate
surgical margins
Journal
Journal of surgical oncology
ISSN: 1096-9098
Titre abrégé: J Surg Oncol
Pays: United States
ID NLM: 0222643
Informations de publication
Date de publication:
Mar 2022
Mar 2022
Historique:
revised:
04
10
2021
received:
24
05
2021
accepted:
09
10
2021
pubmed:
2
11
2021
medline:
5
2
2022
entrez:
1
11
2021
Statut:
ppublish
Résumé
Breast-conserving surgery (BCS) is followed by reoperations in approximately 25%. Reoperations lead to an increased risk of infection and wound healing problems as well as a worse cosmetic outcome. Several technical approaches for an intraoperative margin assessment to decrease the reoperation rate are under evaluation, some of them are still experimental. A prospective single-arm post-marketing study with 60 patients undergoing BCS for ductal carcinoma in situ (DCIS) and invasive breast cancer was conducted. The specimen was intraoperatively examined by the ClearSight™ system, a mobile magnetic resonance imaging system that is based on a diffusion-weighted imaging protocol. However, the results were blinded to the surgeon. The ClearSight™ system was performed for both ductal and lobular breast cancer and DCIS, with a sensitivity of 0.80 (95% confidence interval [CI]: 0.44-0.96) and a specificity of 0.84 (95% CI 0.72-0.92), with an overall diagnostic accuracy of 80%. Had the ClearSight™ been known to the surgeon intraoperatively, the reoperation rate would have been reduced by 83% for invasive carcinoma, from 10% to 2%, and 50% for DCIS, from 30% to 15% reoperations. A trial designed to examine the impact on reoperation rates is currently ongoing.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
Breast-conserving surgery (BCS) is followed by reoperations in approximately 25%. Reoperations lead to an increased risk of infection and wound healing problems as well as a worse cosmetic outcome. Several technical approaches for an intraoperative margin assessment to decrease the reoperation rate are under evaluation, some of them are still experimental.
METHODS
METHODS
A prospective single-arm post-marketing study with 60 patients undergoing BCS for ductal carcinoma in situ (DCIS) and invasive breast cancer was conducted. The specimen was intraoperatively examined by the ClearSight™ system, a mobile magnetic resonance imaging system that is based on a diffusion-weighted imaging protocol. However, the results were blinded to the surgeon.
RESULTS
RESULTS
The ClearSight™ system was performed for both ductal and lobular breast cancer and DCIS, with a sensitivity of 0.80 (95% confidence interval [CI]: 0.44-0.96) and a specificity of 0.84 (95% CI 0.72-0.92), with an overall diagnostic accuracy of 80%.
CONCLUSION
CONCLUSIONS
Had the ClearSight™ been known to the surgeon intraoperatively, the reoperation rate would have been reduced by 83% for invasive carcinoma, from 10% to 2%, and 50% for DCIS, from 30% to 15% reoperations. A trial designed to examine the impact on reoperation rates is currently ongoing.
Identifiants
pubmed: 34724205
doi: 10.1002/jso.26721
pmc: PMC9298117
doi:
Types de publication
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
361-368Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2021 The Authors. Journal of Surgical Oncology published by Wiley Periodicals LLC.
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