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Peer-reviewedCC BY 4.0European Journal of Nuclear Medicine and Molecular Imaging

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

  • M. I. Warmerdam1
  • T. H. Dijkhuis1
  • D. J. G. Linders1
  • C. M. W. Pesch1
  • A. S. L. P. Crobach2
  • A. Matoshi1
  • K. Basiliya3
  • S. H. van den Berg3
  • F. Cailler4
  • K. C. M. J. Peeters1
  • F. A. Holman1
  • J. S. D. Mieog1
3 more authors
  • A. L. Vahrmeijer1
  • D. E. Hilling1,5
  • J. J. Boonstra3
5 affiliations
  1. 1Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
  2. 2Department of Pathology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
  3. 3Department of Gastroenterology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands
  4. 4Surgimab SAS, 10, Parc Club du Millénaire, 1025 Avenue Henri Becquerel, 34000 Montpellier, France
  5. 5Department of Surgical Oncology and Gastrointestinal Surgery, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands
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Abstract

Purpose: Accurate 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.

Methods: Patients 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.

Results: A 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).

Conclusion: Although 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.

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00259-026-08155-z.

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Cite

BibTeXRIS
BibTeX
@article{warmerdam2026ceatargeted,
  title = {{CEA-targeted fluorescence endoscopy for the detection of high-grade dysplasia and early invasive rectal cancer: A proof-of-concept trial}},
  author = {M. I. Warmerdam and T. H. Dijkhuis and D. J. G. Linders and C. M. W. Pesch and A. S. L. P. Crobach and A. Matoshi and K. Basiliya and S. H. van den Berg and F. Cailler and K. C. M. J. Peeters and F. A. Holman and J. S. D. Mieog and A. L. Vahrmeijer and D. E. Hilling and J. J. Boonstra},
  journal = {European Journal of Nuclear Medicine and Molecular Imaging},
  year = {2026},
  month = sep,
  doi = {10.1007/s00259-026-08155-z},
  url = {https://doi.org/10.1007/s00259-026-08155-z},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - CEA-targeted fluorescence endoscopy for the detection of high-grade dysplasia and early invasive rectal cancer: A proof-of-concept trial
AU  - M. I. Warmerdam
AU  - T. H. Dijkhuis
AU  - D. J. G. Linders
AU  - C. M. W. Pesch
AU  - A. S. L. P. Crobach
AU  - A. Matoshi
AU  - K. Basiliya
AU  - S. H. van den Berg
AU  - F. Cailler
AU  - K. C. M. J. Peeters
AU  - F. A. Holman
AU  - J. S. D. Mieog
AU  - A. L. Vahrmeijer
AU  - D. E. Hilling
AU  - J. J. Boonstra
PY  - 2026
DA  - 2026/09/03
JO  - European Journal of Nuclear Medicine and Molecular Imaging
DO  - 10.1007/s00259-026-08155-z
UR  - https://doi.org/10.1007/s00259-026-08155-z
AB  - Purpose: Accurate 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.  Methods: Patients 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.  Results: A 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).  Conclusion: Although 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.  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00259-026-08155-z.
SN  - 1619-7070
SN  - 1619-7089
ER  -