Evidence map›Paper›PMID 39401538›Full record

ArticlePharmacological research2024

Ex vivo fluorescence-guided resection margin assessment in breast cancer surgery using a topically applied, cathepsin-activatable imaging agent.

Daan G J Linders, Okker D Bijlstra, Ethan Walker, Taryn L March, Martin Pool, A Rob P M Valentijn, Tom H Dijkhuis, Jikke N Woltering, Floor R Pijl, Gilbert Noordam and 14 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmacological research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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.

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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. 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

24 authors.

Daan G J LindersDepartment of Surgery, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands.
Okker D BijlstraDepartment of Surgery, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands.
Ethan WalkerDepartment of Biomedical Engineering, Case Western Reserve University, Cleveland, OH 44106, USA.
Taryn L MarchDepartment of Surgery, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands.
Martin PoolDepartment of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands.
A Rob P M ValentijnDepartment of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands.
Tom H DijkhuisDepartment of Surgery, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands.
Jikke N WolteringDepartment of Surgery, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands.
Floor R PijlDepartment of Surgery, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands.
Gilbert NoordamDepartment of Pathology, Haaglanden Medical Center, The Hague 2512 VA, The Netherlands.
Davey van den BurgDepartment of Pathology, Haaglanden Medical Center, The Hague 2512 VA, The Netherlands.
Joost R M van der SijpDepartment of Surgery, Haaglanden Medical Center, The Hague 2512 VA, The Netherlands.
Onno R GuicheritDepartment of Surgery, Haaglanden Medical Center, The Hague 2512 VA, The Netherlands.
Andreas W K S MarinelliDepartment of Surgery, Haaglanden Medical Center, The Hague 2512 VA, The Netherlands.
Jacobus BurggraafCentre for Human Drug Research, Leiden 2333 CL, The Netherlands; Leiden Academic Center for Drug Research, Leiden University, Leiden 2300 RA, The Netherlands.
Robert RissmannCentre for Human Drug Research, Leiden 2333 CL, The Netherlands; Leiden Academic Center for Drug Research, Leiden University, Leiden 2300 RA, The Netherlands.
Matthew BogyoDepartment of Microbiology and Immunology, Stanford University, Stanford, CA 94305, USA.
Denise E HillingDepartment of Surgery, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands; Department of Surgical Oncology and Gastrointestinal Surgery, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam 3015 GD, The Netherlands.
Peter J K KuppenDepartment of Surgery, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands.
Brian StraightAkrotome Imaging Inc., Cleveland, OH 44106, USA.
Marieke E StraverDepartment of Surgery, Haaglanden Medical Center, The Hague 2512 VA, The Netherlands.
Hans Marten HazelbagDepartment of Pathology, Haaglanden Medical Center, The Hague 2512 VA, The Netherlands.
James P BasilionDepartment of Biomedical Engineering, Case Western Reserve University, Cleveland, OH 44106, USA; Akrotome Imaging Inc., Cleveland, OH 44106, USA; Department of Radiology, Case School of Medicine, Case Western Reserve University, Cleveland, OH 44106, USA. Electronic address: jxb206@case.edu.
Alexander L VahrmeijerDepartment of Surgery, Leiden University Medical Center, Leiden 2333 ZA, The Netherlands. Electronic address: a.l.vahrmeijer@lumc.nl.

Funding

Fluorescence-guided resection of breast tumors using a topically-applied molecular probeR01CA246678 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI BASILION, JAMES PETER · 2020 to 2025
$2.8M
NCI NIH HHS R01 CA246678
6 · The paper itself

Abstract

Up to 40 % of breast cancer patients have a tumor-positive resection margin (TPRM) - defined as cancer cells at the surface of the resected specimen - after breast-conserving surgery (BCS), necessitating re-resection or boost radiation. To prevent these additional treatments, intraoperative near-infrared (NIR) fluorescence imaging with the topically applied, cathepsin-activatable imaging agent AKRO-6qcICG might be used to detect TPRMs and guide additional resection. Here, to validate its performance, the agent is topically applied to all surfaces of freshly resected breast cancer specimens (n = 11 patients) and to 3-5 mm thick tissue slices of the specimens (n = 26 patients). NIR fluorescence images of the resection surfaces and tissue slices are acquired and correlated to final histopathology. AKRO-6qcICG detects TPRMs with a sensitivity, specificity, PVV, and NPV of 100 %, 67 %, 10 %, and 100 %, respectively. On the tissue slices, the fluorescence signal has a median tumor-to-background ratio of 1.8. These findings indicate that topically applied AKRO-6qcICG can visualize TPRMs ex vivo with a high sensitivity and NPV, with sufficient contrast to adjacent healthy breast tissue.

Indexed as

Breast NeoplasmsCathepsinsMargins of ExcisionOptical ImagingAdministration, TopicalAdultAgedFemaleFluorescent DyesHumansMastectomy, SegmentalMiddle AgedCathepsinsFluorescent DyesActivatable probesBreast cancerCathepsinsFluorescence-guided surgeryTopical application

Identifiers

PMID39401538
PMCPMC12318534

What OpenQuestion holds

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Registered trials

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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.