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 et al.
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In 30 seconds
This proof-of-concept clinical trial assessed whether carcinoembryonic antigen (CEA)-targeted near-infrared fluorescence imaging could distinguish advanced rectal polyps containing high-grade dysplasia or early invasive carcinoma (HGD/IC) from those containing only low-grade dysplasia (LGD). Twenty-two patients scheduled for local en-bloc endoscopic resection received intravenous SGM-101. Ex vivo bread-loaf imaging showed a median tumour-to-LGD ratio of 1.7 (IQR 1.3-2.9). For detecting HGD/IC, sensitivity was 86% (2 false-negatives) and specificity was 88% (1 false-positive). The findings support proof-of-concept, but clinical utility remains unestablished.
Key findings
- Among 22 patients, 13 had HGD/IC and 9 had LGD-only polyps.
- Ex vivo bread-loaf imaging yielded a median tumour-to-LGD ratio of 1.7 (IQR 1.3-2.9).
- Sensitivity for HGD/IC was 86% (2 false-negatives), and specificity was 88% (1 false-positive).
- Median tumour-to-LGD ratio was 2.5 (2.0-3.5) with 10 mg versus 1.3 (1.2-1.6) with 5 mg SGM-101 (p = 0.023).
Why it matters
Distinguishing advanced dysplasia or early invasion from low-grade dysplasia can inform selection of local resection technique. CEA-targeted fluorescence imaging showed measurable discrimination in this proof-of-concept study, suggesting a potential adjunct to optical assessment of advanced rectal polyps. Its diagnostic performance and effect on treatment decisions or patient outcomes require further evaluation.
What to keep in mind
The study included only 22 patients, and the authors state that clinical utility, including effects on treatment decisions and patient outcomes, remains to be demonstrated in larger prospective studies.