Clinical trial · Interventional
Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties with patients recruitment, study acceptance and protocol implementation.
Summary
Brief summary (as posted)
This innovative study will involve the use of probe-based confocal laser endomicroscopy, a new medical imaging technology never used for surgical indications to date. Virtual biopsies (pCLE images) will be compared to histopathology analysis. This study focuses on the evaluation of rectal tumor margins. The hypothesis is that pCLE will allow identification of rectal tumor margin, comparable to that of histopathology. In the future, decision of resection margin could rely on intraoperative pCLE exam. The proposed study is a feasibility study, first in the indication of rectal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy and resection | Procedure | — | UNRESOLVED |
| EUS | Procedure | — | UNRESOLVED |
| Probe-based confocal laser endomicroscopy | Device | — | UNRESOLVED |
| Rectoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Concordance in identification of lower pole of tumor
- timeFrame
- Up to 9 months
- description
- Identification of lower pole of tumor will be compared between pCLE (optical images, virtual biopsies) and conventional histopathology (biopsies, postoperative analysis of resected piece). Samples of tumor tissue and closest tissue thought to be disease-free. Conventional biopsies and virtual biopsies prior to radiochemotherapy start (if applicable) and during surgery.
Secondary outcomes (5)
- measure
- Identification of tissue characteristics
- timeFrame
- Up to 9 months
- description
- Microvascularisation density, general microstructure, image interpretation criteria, true/false positive/negative. Will be assessed for all patients at the time of surgical procedure. Also prior to treatment for patients undergoing radiochemotherapy.
- measure
- Concordance of techniques (pCLE and histopathology)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient, male or female over 18 years old * Patient with rectal adenocarcinoma : * stage T1 or T2, N0 (one single evaluation, during resection) * stage N+ or T3 (pre- and post-radiochemotherapy evaluations) * Absence of contra-indication to rectoscopy conduct * Patient able to understand the study and to provide written informed consent * Patient registered with the French social security regime Non-inclusion criteria: * Absence of written informed consent * Patient with known or suspected allergy to fluorescein * Patient with history of reaction jeopardizing the vital prognosis during angiography * Patient with history of multiple or serious allergic reaction to drugs * Patient presenting, in the investigator's judgment, a condition or disease preventing their participation to study procedures * Patient pregnant or breast-feeding * Patient within exclusion period from other clinical trial * Patient having forfeited their freedom of an administrative or legal obligation * Patient being under guardianship
References
Publications (1)
- RESULTWijsmuller AR, Ghnassia JP, Varatharajah S, Schaeffer M, Leroy J, Marescaux J, Ignat M, Mutter D. Prospective Trial on Probe-Based Confocal Laser Endomicroscopy for the Identification of the Distal Limit in Rectal Adenocarcinoma. Surg Innov. 2018 Aug;25(4):313-322. doi: 10.1177/1553350618773011. Epub 2018 May 7. PMID 29732957