Evidence map›Paper›PMID 42690333›Full record

ArticleEuropean journal of nuclear medicine and molecular imaging2026

CEA-targeted fluorescence endoscopy for the detection of high-grade dysplasia and early invasive rectal cancer: A proof-of-concept trial.

M I Warmerdam, T H Dijkhuis, D J G Linders, C M W Pesch, A S L P Crobach, A Matoshi, K Basiliya, S H van den Berg, F Cailler, K C M J Peeters and 5 more

Registry-linked trialAbstract read
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In one paragraph

Article in European journal of nuclear medicine and molecular imaging, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06280690 (SGM-101 Tumor-targeted Fluorescence Endoscopy to Enable Discrimination of Malignant From Benign Tissue in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia), which is not on this map. Not yet cited in PubMed.

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

NCT06280690 phase2unknown statusnot on this map

SGM-101 Tumor-targeted Fluorescence Endoscopy to Enable Discrimination of Malignant From Benign Tissue in Rectal Polyps With Suspected T1 Adenocarcinoma or High Grade Dysplasia: a Feasibility Study

TypeinterventionalSponsorLeiden University Medical CenterRan2024 to 2025Enrolled20ConditionsColorectal Cancer, Image, Low Grade Dysplasia of ColonArmsSGM-101
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

M I WarmerdamDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands. m.i.warmerdam@lumc.nl.ORCID http://orcid.org/0000-0002-4546-5966
T H DijkhuisDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
D J G LindersDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
C M W PeschDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
A S L P CrobachDepartment of Pathology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
A MatoshiDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
K BasiliyaDepartment of Gastroenterology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
S H van den BergDepartment of Gastroenterology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
F CaillerSurgimab SAS, 10, Parc Club du Millénaire, 1025 Avenue Henri Becquerel, 34000, Montpellier, France.
K C M J PeetersDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
F A HolmanDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
J S D MieogDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
A L VahrmeijerDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
D E HillingDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.
J J BoonstraDepartment of Gastroenterology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAccurate recognition of high-grade dysplasia (HGD) and early invasive carcinoma (IC) within colorectal polyps is essential for selecting the preferred local resection technique. However, optical endoscopic diagnosis can be challenging, particularly in large and advanced polyps. This study investigates whether carcinoembryonic antigen (CEA)-targeted near-infrared fluorescence (NIRF) imaging can distinguish polyps containing HGD/IC from polyps solely containing low-grade dysplasia (LGD), given prior evidence of CEA overexpression in HGD/IC relative to LGD.

methodsPatients scheduled for local en-bloc endoscopic resection of advanced rectal polyps were included in the study and received 5 mg or 10 mg intravenous SGM-101, a CEA-targeted fluorescent agent. In vivo imaging was performed using a rigid Quest-Olympus NIRF-endoscope, followed by ex vivo whole-specimen and bread-loaf imaging using the PEARL imaging system. The primary endpoint was the NIRF tumour-to-low-grade-dysplasia ratio (TDR; HGD/IC divided by LGD) performed on bread loafs, as this method enabled direct pathological correlation. Secondary endpoints included dose-finding as well as sensitivity and specificity for detecting HGD/IC.

resultsA total of 22 patients were included, with 9/22 containing LGD only and 13/22 containing HGD/IC. Eleven patients received 10 mg and 11 received 5 mg SGM-101. Ex vivo bread-loaf imaging showed a median (IQR) TDR of 1.7 (1.3-2.9), with higher values in the 10 mg group of 2.5 (2.0-3.5) compared to the 1.3 (1.2-1.6) in the 5 mg group (p = 0.023). The sensitivity for detecting HGD/IC was 86% (2 false-negatives), and specificity was 88% (1 false-positive).

conclusionAlthough with limited sample size, this study demonstrates proof-of-concept of CEA-targeted NIRF-imaging in differentiating HGD/IC bearing polyps from completely benign LGD polyps. Clinical utility, including its impact on treatment decision-making and patient outcomes, remains to be demonstrated in future, larger prospective studies. CLINICAL TRIAL REGISTRATION NUMBER: NCT06280690.

Indexed as

CEA-targeted imagingColorectal polypsEarly colorectal cancerFluorescence-guided endoscopy

Identifiers

PMID42690333

What OpenQuestion holds

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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.