Lumeneye Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer

NCT06189846 | Completed

• 1 other identifier: BCIA 2023/02
• Study Type: observational
• Target: 82
• Locations: 5 countries
• Sites: 8

Brief Summary

The objective of this prospective international cohort is to evaluate the LUMENEYE rectoscope for assessment on tumor response after total neoadjuvant treatment in rectal cancer. Patients included in this study will be patients who initially will be good candidates for organ preservation. The participating centers are all expert centers in tumor assessment. All patient assessments after neoadjuvant treatment for rectal adenocarcinoma will be included in each centre.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• The rate of complete and/or nearly complete response

  To evaluate the complete and/or nearly complete response with LumenEye digital endoscopescope

  From 8 weeks to 24 weeks after the end of radiotherapy

Secondary Outcomes (5)

• Agreement for grading rectal tumour response between the endoscopic and MRI assessment of tumour response

  From 8 weeks to 24 weeks after the end of radiotherapy

• Agreement for grading rectal tumour response between the clinical and endoscopic assessment of tumour response

  From 8 weeks to 24 weeks after the end of radiotherapy

• Agreement for grading rectal tumour response between the clinical and MRI assessment of tumour response.

  From 8 weeks to 24 weeks after the end of radiotherapy

• Interobserver agreement for grading rectal tumour response using a digital rectoscope platform

  From 8 weeks to 24 weeks after the end of radiotherapy

• Rate of changing attitude after using the digital rectoscope platform (intra-observer changing management).

  From 8 weeks to 24 weeks after the end of radiotherapy

Interventions

International Cohort DEVICE

Assessing tumour response following neoadjuvant treatment in rectal cancer include : * Digital rectal examination * Rectal MRI * Rectoscopy ( Lumeneye device) The monitoring of tumour response intervals up to 6 months following completion of the neoadjuvant treatment at 8 weeks, at 16 weeks, at 24 weeks after the end of neoadjuvant treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

These are patients with small rectal cancer, initially good candidates for organ preservation and whose evaluation is done by clinical and radiological examination and with the Lumeneye rectoscope

You may qualify if:

• Patient ≥ 18 years
• Histologically confirmed diagnosis of adenocarcinoma of the rectum,
• Patient who received radiotherapy and chemotherapy (TNT) or immunotherapy
• Stage cT2T3
• cN0 or cN1 (≤ 3 positive LN or size ≤ 8 mm)
• no metastases
• Baseline Tumour size ≤ 5 cm (MRI)
• Baseline Tumour ≤ 8 from anal verge
• Ability to consent.
• Oral agreement after reading information letter

You may not qualify if:

• Tumour cT1 or cT4
• Baseline Tumour size \> 5cm
• Invaded external sphincter or levator muscle
• Tumour cN2 (\> 3 positive LN or size \> 8 mm)
• Metastasis
• History of Inflammatory bowel disease
• Patient with a history of pelvic radiotherapy or chemotherapy
• Pregnant patients
• Protected adults (individuals under guardianship by court order).

Sponsors & Collaborators

• Bordeaux Colorectal Institute Academy: lead

Study Sites (8)

Clinique Tivoli-Ducos - Bordeaux Colorectal Institute

Bordeaux, France

Location

Hôpital Européen de Marseille

Marseille, France

Location

Hôpital Saint-Antoine - APHP

Paris, France

Location

CHU de ROUEN

Rouen, France

Location

Humanitas Research Hospital

Milan, Italy

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

University Hospital Vall D'Hebron

Barcelona, Spain

Location

Imperial College London

London, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Quentin DENOST

  Bordeaux Colorectal Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: January 4, 2024
• Primary Completion: October 17, 2025
• Study Completion: March 5, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (1); FR (4); NL (1); GB (1)