Evidence map›Paper›PMID 40471424›Full record

Trial reportMolecular imaging and biology2025

Long-term Local Control Following CEA-targeted Fluorescence-guided Surgery in Patients With Locally Advanced and Recurrent Rectal Cancer.

Mats I Warmerdam, Davy M J Creemers, Miranda Kusters, Koen C M J Peeters, Fabian A Holman, J Sven D Mieog, Francoise Cailler, Pim J W A Burger, Jacobus Burggraaf, Harm J T Rutten and 3 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Molecular imaging and biology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

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

  1. Pooled it
  2. Translation of Intraoperative Molecular Imaging for Clinical Use.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Review
  3. Review
  4. 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

13 authors.

Mats I WarmerdamDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands. m.i.warmerdam@lumc.nl.ORCID 0000-0002-4546-5966
Davy M J CreemersDepartment of Surgery, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.
Miranda KustersDepartment of Surgery, Amsterdam University Medical Center (AUMC), Amsterdam, The Netherlands.
Koen C M J PeetersDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Fabian A HolmanDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
J Sven D MieogDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Francoise Cailler, Surgimab, Montpellier, France.
Pim J W A BurgerDepartment of Surgery, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.
Jacobus BurggraafCenter for Human Drug Research (CHDR), Leiden, The Netherlands.
Harm J T RuttenDepartment of Surgery, Catharina Hospital Eindhoven, Eindhoven, The Netherlands.
Cornelis VerhoefDepartment of Surgical Oncology and Gastrointestinal Surgery, Erasmus MC Cancer Institute, Rotterdam University Medical Center, Rotterdam, The Netherlands.
Alexander L VahrmeijerDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Denise E HillingDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn our previous phase 2 trial, patients with locally advanced (LARC) or locally recurrent rectal cancer (LRRC) received SGM-101, a CEA-targeted fluorescent agent, to enable real-time near-infrared fluorescence (NIRF) guided surgery. This study demonstrated that SGM-101 enabled additional tumor removal in some patients and supported less invasive surgery in others. Despite this positive intraoperative effect, the impact on long-term tumor control is unknown. Therefore, in this article we report the long-term outcomes of all rectal cancer patients that participated to the trial. PROCEDURES: For all 29 LARC and LRRC patients that participated in the SGM-101 phase 2 trial, follow-up data were collected. Main outcome measure was 5-year local tumor control.

resultsThe median follow-up of all patients was 5.0 years (IQR 4.5-5.5). Of the 12 LARC patients, three (25%) patients developed a local recurrence. The two patients in whom NIRF-guided surgery resulted in less invasive surgery remained locally recurrence-free. Among the 17 patients undergoing curative surgery for LRRC, 11 (65%) patients developed a local re-recurrence. Of the three patients who had an R0 instead of R1 as a direct result of SGM-101 guided surgery, one patient developed a local re-recurrence (33%), while the other two remained local recurrence-free.

conclusionsThis is the first study to report follow-up data on patients undergoing tumor-targeted NIRF-guided surgery. Although SGM-101 resulted in warranted changes in surgical management intra-operatively, no improved long-term benefit could be observed for the entire cohort. However, the subset of patients whose surgical approach was modified based on NIRF - either by performing less invasive surgery or removing additional malignant tissue-showed favorable long-term outcomes. Results from ongoing large trials are awaited.

Indexed as

Carcinoembryonic AntigenNeoplasm Recurrence, LocalRectal NeoplasmsSurgery, Computer-AssistedAgedFemaleFluorescenceFollow-Up StudiesHumansMaleMiddle AgedTreatment OutcomeCarcinoembryonic AntigenCEA-targeted imagingColorectal neoplasiaFluorescenceFollow-upNear-infrared guided surgeryOptical imagingSurvival

Identifiers

PMID40471424
PMCPMC12405016

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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.