Using a special fluorescent probe to improve detection of early rectal cancer during endoscopy
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
This study is testing a special fluorescent probe to see if it can help doctors better detect early rectal cancer during endoscopy for patients with suspected T1 cancer or high-grade dysplasia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden) |
| Trial ID | NCT06280690 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of SGM-101, a tumor-targeted fluorescent probe, in distinguishing between invasive T1 carcinoma or high-grade dysplasia and low-grade dysplasia during endoscopic procedures. Patients with suspected T1 rectal cancer or high-grade dysplasia will undergo local endoscopic resection, and the study aims to enhance the accuracy of cancer detection in large rectal polyps. By utilizing fluorescence-guided endoscopy, the trial seeks to improve patient outcomes by ensuring appropriate resection techniques are applied based on accurate diagnoses.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with suspected T1 rectal cancer or high-grade dysplasia scheduled for local endoscopic en-bloc resection.
Not a fit: Patients with prior participation in this study or those with conditions that jeopardize their well-being may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and appropriate treatment plans for patients with early rectal cancer.
How similar studies have performed: While this approach is novel, previous studies have shown varying success rates in optical diagnosis of early rectal cancer, indicating a need for improved methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient must have suspected T1RC/HGD and scheduled for a local endoscopic en-bloc resection. The rectum is defined as the area between the linea dentata and 10cm ab ano. 2. Age \> 18 years old 3. Patients should be capable and willing to give signed informed consent before study specific procedures. Exclusion Criteria: 1. Prior participation in this study 2. Previous administration of SGM-101 3. Patients with a history of anaphylactic shock 4. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential 5. Any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives.
Where this trial is running
Leiden
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
Study contacts
- Study coordinator: Mats Warmerdam, Msc
- Email: m.i.warmerdam@lumc.nl
- Phone: +31715298420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.