Evidence map›Paper›PMID 40478342›Full record

ArticleAnnals of surgical oncology2025

A Multi-institutional Study to Evaluate the Effectiveness and Safety of a Supine MRI-Based Guidance System, the Breast Cancer Locator

Marc Thill, Matteo Ghilli, Manuella Roncella, Katharina Kelling, Hisham Fansa, Michael Golatta, Joerg Heil, Viviane Haasteren, Amelie Freitag, Riku Togawa and 4 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Annals of surgical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06461663 (An Interventional, Post-Market Study to Evaluate the Performance of a Custom-made Medical Device, "Breast Cancer Locator), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06461663 nacompletednot on this map

An Interventional, Post-Market Study to Evaluate the Performance of a Custom-made Medical Device, "Breast Cancer Locator (BCL)" System, in Breast-conserving Surgery (BCS)

TypeinterventionalSponsorCairnSurgical, Inc.Ran2022 to 2024Enrolled35ConditionsBreast CancerArmsBreast Cancer Locator Guided Breast Conserving Surgery
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Marc ThillAgaplesion Markus Krankenhaus, Frankfurt, Germany. marc.thill@agaplesion.de.ORCID http://orcid.org/0000-0002-8800-8044
Matteo GhilliAzienda Ospedaliero Universitaria Pisana, Pisa, Italy.
Manuella RoncellaAzienda Ospedaliero Universitaria Pisana, Pisa, Italy.
Katharina KellingAgaplesion Markus Krankenhaus, Frankfurt, Germany.
Hisham FansaSpital Zollikerberg, Zurich, Switzerland.
Michael GolattaBreast Unit Heidelberg, St. Elisabeth Hospital, Heidelberg, Germany.
Joerg HeilBreast Unit Heidelberg, St. Elisabeth Hospital, Heidelberg, Germany.
Viviane HaasterenAgaplesion Markus Krankenhaus, Frankfurt, Germany.
Amelie FreitagBreast Unit Heidelberg, St. Elisabeth Hospital, Heidelberg, Germany.
Riku TogawaDepartment of Obstetrics and Gynecology, Heidelberg University Hospital, Heidelberg, Germany.
Andrea SagonaHumanitas Research Hospital, Milan, Italy.
Timothy B RooneyDepartment of Radiology and Medical Imaging, University of Virginia, Charlottesville, VA, USA.
Misty J FoxCairnSurgical, Inc., Lebanon, NH, USA.
Richard J BarthCairnSurgical, Inc., Lebanon, NH, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Breast Cancer Locator PATIENTS AND

methodsSupine magnetic resonance imaging (MRI) images were used to generate (1) an interactive three-dimensional (3D) virtual image of the tumor in the breast and (2) a plastic bra-like form (BCL) that enabled the surgeon to place wires that bracketed the tumor volume. The primary objective was to determine the proportion of patients undergoing margin negative resections.

resultsA total of 35 subjects were enrolled at 5 sites by 9 surgeons. In the 33 patients treated per protocol, 31 had margin negative resections (94%). All 31 patients with negative margins had negative margins on the primary lumpectomy specimen resected with BCL guidance. Additional shave margins were taken in 4 of the 31 patients; no cancer was present in the shaves. A total of 25 patients had invasive ductal carcinoma, 7 invasive lobular carcinoma, and 3 ductal carcinoma en situ (DCIS). The mean tumor diameter was 3.1 cm and specimen volume was 56 ml. The median actual/targeted specimen volume ratio was 1.18. There was no significant difference in preop versus postop Breast-Q scores: 66.5 versus 64.0, p = 0.58. Surgeons judged the BCL guidance system to be easy to use in 91% of cases.

conclusionsThe BCL guidance system enabled surgeons to do precise BCS: margin negative resections were obtained in a high proportion of cases, resected specimen volumes were relatively low, and patients' satisfaction with their breasts was not adversely effected by surgery.

Indexed as

Breast cancerBreast conserving surgeryGuidance deviceLumpectomySupine MRI

Identifiers

PMID40478342

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.