Evidence map›Paper›PMID 31898104›Full record

ArticleAnnals of surgical oncology2020

Feasibility Study of a Novel Protease-Activated Fluorescent Imaging System for Real-Time, Intraoperative Detection of Residual Breast Cancer in Breast Conserving Surgery.

Barbara L Smith, Conor R Lanahan, Michelle C Specht, Bridget N Kelly, Carson Brown, David B Strasfeld, Jorge M Ferrer, Upahvan Rai, Rong Tang, Travis Rice-Stitt and 3 more

Erratum issuedOpen access · hybridAbstract read
In one paragraph

Article in Annals of surgical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 16% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  16. Precision Surgery Guided by Intraoperative Molecular Imaging.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022
    Review
  17. Review
  18. Review
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  20. Targeted optical fluorescence imaging: a meta-narrative review and future perspectives.European journal of nuclear medicine and molecular imaging · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Barbara L SmithDivision of Surgical Oncology, Massachusetts General Hospital, Boston, MA, USA. blsmith1@mgh.harvard.edu.
Conor R LanahanDivision of Surgical Oncology, Massachusetts General Hospital, Boston, MA, USA.
Michelle C SpechtDivision of Surgical Oncology, Massachusetts General Hospital, Boston, MA, USA.
Bridget N KellyDivision of Surgical Oncology, Massachusetts General Hospital, Boston, MA, USA.
Carson BrownDivision of Surgical Oncology, Massachusetts General Hospital, Boston, MA, USA.
David B StrasfeldLumicell, Inc, Newton, MA, USA.
Jorge M FerrerLumicell, Inc, Newton, MA, USA.
Upahvan RaiDivision of Surgical Oncology, Massachusetts General Hospital, Boston, MA, USA.
Rong TangDivision of Surgical Oncology, Massachusetts General Hospital, Boston, MA, USA.
Travis Rice-StittDepartment of Pathology, Massachusetts General Hospital, Boston, MA, USA.
Anna BiernackaDepartment of Pathology, Massachusetts General Hospital, Boston, MA, USA.
Elena F BrachtelDepartment of Pathology, Massachusetts General Hospital, Boston, MA, USA.
Michele A GaddDivision of Surgical Oncology, Massachusetts General Hospital, Boston, MA, USA.
Massachusetts General Hospital · USLumicell (United States) · US

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
Phase II clinical study of real-time tumor bed imaging in breast cancer patientsR21CA173762 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI SMITH, BARBARA LYNN · 2013 to 2014
$512k
NCATS NIH HHS UL1 TR001102NCI NIH HHS 1R21CA173762-01NCI NIH HHS R21 CA173762
6 · The paper itself

Abstract

backgroundObtaining tumor-free margins is critical to prevent recurrence after lumpectomy for breast cancer. Unfortunately, current approaches leave positive margins that require second surgeries in 20-40% of patients. We assessed the LUM Imaging System for real-time, intraoperative detection of residual tumor.

methodsBreast lumpectomy cavity walls and excised specimens were assessed with the LUM Imaging System after 1 mg/kg intravenous LUM015, a protease-activatable fluorescent agent. Fluorescence at potential sites of residual tumor in lumpectomy cavity walls was evaluated intraoperatively with a sterile hand-held probe, with real-time predictive results displayed on a monitor intraoperatively, and later correlated with histopathology.

resultsIn vivo lumpectomy cavities and excised specimens were imaged after LUM015 injection in 45 women undergoing breast cancer surgery. Invasive ductal and lobular cancers and intraductal cancer (DCIS) were included. A total of 570 cavity margin surfaces in 40 patients were used for algorithm development. Image analysis and display took approximately 1 s per 2.6-cm-diameter circular margin surface. All breast cancer subtypes could be distinguished from adjacent normal tissue. For all imaged cavity surfaces, sensitivity for tumor detection was 84%. Among 8 patients with positive margins after standard surgery, sensitivity for residual tumor detection was 100%; 2 of 8 were spared second surgeries because additional tissue was excised at sites of LUM015 signal. Specificity was 73%, with some benign tissues showing elevated fluorescent signal.

conclusionsThe LUM015 agent and LUM Imaging System allow rapid identification of residual tumor in the lumpectomy cavity of breast cancer patients and may reduce rates of positive margins.

Indexed as

Intraoperative CareAdultAgedBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularDiagnostic ImagingFeasibility StudiesFemaleFluorescent DyesFollow-Up StudiesHumansMastectomy, SegmentalMiddle AgedNeoplasm InvasivenessNeoplasm Recurrence, LocalFluorescent DyesPeptide Hydrolases

Identifiers

PMID31898104
PMCPMC7210242
OpenAlexW2998511593

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.