Evidence map›Paper›PMID 37552367›Full record

Trial reportEuropean journal of nuclear medicine and molecular imaging2024

Intraoperative molecular imaging of colorectal lung metastases with SGM-101: a feasibility study.

Ruben P J Meijer, Hidde A Galema, Robin A Faber, Okker D Bijlstra, Alexander P W M Maat, Françoise Cailler, Jerry Braun, Stijn Keereweer, Denise E Hilling, Jacobus Burggraaf and 3 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in European journal of nuclear medicine and molecular imaging, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04737213 (An Open-label, Exploratory Study Assessing the Feasibility of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Lung Metastasis in Colorectal Cancer), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT04737213 phase2unknown statusnot on this map

An Open-label, Exploratory Study Assessing the Feasibility of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Lung Metastasis in Colorectal Cancer

TypeinterventionalSponsorLeiden University Medical CenterRan2020 to 2021Enrolled10ConditionsColorectal Cancer, Metastatic Colon CancerArmsSGM-101
3 · Its place in the literature

Who cites it

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

  1. Pooled it
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  10. Tissue-seeking dyes for in vivo applications.Smart molecules : open access · 2024
    Review
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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

13 authors.

Ruben P J MeijerDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Hidde A GalemaDepartment of Surgical Oncology and Gastrointestinal Surgery, Erasmus MC Cancer Institute, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.
Robin A FaberDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Okker D BijlstraDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Alexander P W M MaatDepartment of Cardiothoracic Surgery, Erasmus Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.
Françoise CaillerSurgimab, 10 Parc Club du Millénaire, 1025 Avenue Henri Becquerel, 34000, Montpellier, France.
Jerry BraunDepartment of Cardiothoracic Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Stijn KeereweerDepartment of Otorhinolaryngology, Head and Neck Surgery, Erasmus MC Cancer Institute, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.
Denise E HillingDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Jacobus BurggraafDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Alexander L VahrmeijerDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
Merlijn HuttemanDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands. merlijn.hutteman@radboudumc.nl.
SGM-CLM study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMetastasectomy is a common treatment option for patients with colorectal lung metastases (CLM). Challenges exist with margin assessment and identification of small nodules, especially during minimally invasive surgery. Intraoperative fluorescence imaging has the potential to overcome these challenges. The aim of this study was to assess feasibility of targeting CLM with the carcinoembryonic antigen (CEA) specific fluorescent tracer SGM-101.

methodsThis was a prospective, open-label feasibility study. The primary outcome was the number of CLM that showed a true positive fluorescence signal with SGM-101. Fluorescence positive signal was defined as a signal-to-background ratio (SBR) ≥ 1.5. A secondary endpoint was the CEA expression in the colorectal lung metastases, assessed with the immunohistochemistry, and scored by the total immunostaining score.

resultsThirteen patients were included in this study. Positive fluorescence signal with in vivo, back table, and closed-field bread loaf imaging was observed in 31%, 45%, and 94% of the tumors respectively. Median SBRs for the three imaging modalities were 1.00 (IQR: 1.00-1.53), 1.45 (IQR: 1.00-1.89), and 4.81 (IQR: 2.70-7.41). All tumor lesions had a maximum total immunostaining score for CEA expression of 12/12.

conclusionThis study demonstrated the potential of fluorescence imaging of CLM with SGM-101. CEA expression was observed in all tumors, and closed-field imaging showed excellent CEA specific targeting of the tracer to the tumor nodules. The full potential of SGM-101 for in vivo detection of the tracer can be achieved with improved minimal invasive imaging systems and optimal patient selection.

trial registrationThe study was registered in ClinicalTrial.gov under identifier NCT04737213 at February 2021.

Indexed as

Colorectal NeoplasmsFeasibility StudiesLung NeoplasmsAgedCarcinoembryonic AntigenFemaleFluorescent DyesHumansIntraoperative PeriodMaleMiddle AgedMolecular ImagingOptical ImagingProspective StudiesCarcinoembryonic AntigenFluorescent DyesCarcinoembryonic antigenCEACAM5Colorectal lung metastasesMolecular imagingNear-infrared fluorescence imagingSGM-101

Identifiers

PMID37552367
PMCPMC11300526

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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.