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

March 12, 2024 updated by: Bordeaux Colorectal Institute Academy

Prospective Study Incorporating LUMENEYE Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The recent validation of the Total Neoadjuvant Treatment (TNT) protocol and the improvement of techniques for evaluating tumor response are two major factors in the development of organ preservation in rectal cancer.

Although recent publications have shown promising results of the two organ preservation strategies, Watch & Wait and Local excision, with a low oncological risk, some challenges remain to be addressed before the generalization of rectal preservation in clinical practice.

Among these challenges, the improvement of patient selection and methods for evaluating tumor response appear necessary. The monitoring scheme for the tumor response has not yet been clearly established, but a 6 months programme of tumor response assessment has been recently published (Boubaddi EJSO 2023). Monitoring must consist of a clinical assessment (rectal examination and/or rectoscopy) and additional morphological examinations (rectal MRI) every two months.

Tumor response after neoadjuvant treatment by MRI (TRG 1-5, Tumor Regression Grade) is established as a reliable method of tumor response assessment and accurate diagnosis of complete clinical response. However, discrepancies between clinical examination and radiological MRI may exist and patients undergoing watch-and-wait who develop local regrowth due to mistake in initial tumour response assessment are at higher risk for development of distant metastases (Sao Juliao DCR 2023) with a poor impact on long term oncological results.

The development of the LumenEye digital rectoscope by the SurgEase company enables a comfortable and efficient scoping for the user and the patient (Lewis J BJGP Open 2022). With high quality images of Full HD images and video associated with a secure and connected intuitive software platform, this endoscope can have its place in the monitoring of tumor response.

The contribution of this technology to the monitoring of the tumor response needs to be assessed. This medical device is CE marked and used in its intended purpose.

The objective of this study is to evaluate the complete and/or nearly complete response with LumenEye digital rectoscope.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
      • Marseille, France
        • Recruiting
        • Hôpital Européen de Marseille
        • Contact:
          • Antoine CAMERLO
      • Paris, France
        • Not yet recruiting
        • Hôpital Saint-Antoine - APHP
        • Contact:
          • Jérémie LEFEVRE
      • Rouen, France
        • Not yet recruiting
        • CHU de ROUEN
        • Contact:
          • Jean-Jacques TUECH
  • Italy
      • Milan, Italy
        • Not yet recruiting
        • Humanitas Research Hospital
        • Contact:
          • Antonino SPINELLI
  • Netherlands
      • Amsterdam, Netherlands
        • Not yet recruiting
        • Amsterdam UMC
        • Contact:
          • Roel HOMPES
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • University Hospital Vall d'Hebron
        • Contact:
          • Eloy ESPIN
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Imperial College London
        • Contact:
          • James KINROSS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of complete and/or nearly complete response
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement for grading rectal tumour response between the endoscopic and MRI assessment of tumour response
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
To evaluate the concordance between the endoscopic and MRI assessment of tumor 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
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
- To evaluate the concordance between the clinical and endoscopic assessment of tumor 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.
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
To evaluate the concordance between the clinical and MRI assessment of tumor response.
From 8 weeks to 24 weeks after the end of radiotherapy
Interobserver agreement for grading rectal tumour response using a digital rectoscope platform
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
To assess the interobserver reproducibility of endoscopic response with LumenEye digital endoscope within 6 months after the end of neoadjuvant treatment.
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).
Time Frame: From 8 weeks to 24 weeks after the end of radiotherapy
To evaluate the contribution of the digital ectoscope platform in the surgeon's decision-making
From 8 weeks to 24 weeks after the end of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bordeaux Colorectal Institute Academy

Investigators

  • Study Director: Quentin DENOST, Bordeaux Colorectal Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCIA 2023/02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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