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

Rectal Cancer Clinical Trial

— LUMEVAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189846
• Other study ID #: BCIA 2023/02
• Status: Recruiting
• Start date: January 4, 2024
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Bordeaux Colorectal Institute Academy
• Contact: Quentin DENOST, Prof
• Phone: +33 547501575
• Email: q.denost[@]bordeaux-colorectal-institute.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• International Cohort
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.

Locations

Country	Name	City	State
France	Clinique Tivoli-Ducos - Bordeaux Colorectal Institute	Bordeaux
France	Hôpital Européen de Marseille	Marseille
France	Hôpital Saint-Antoine - APHP	Paris
France	CHU de ROUEN	Rouen
Italy	Humanitas Research Hospital	Milan
Netherlands	Amsterdam UMC	Amsterdam
Spain	University Hospital Vall D'Hebron	Barcelona
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Bordeaux Colorectal Institute Academy

Countries where clinical trial is conducted

France,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Agreement for grading rectal tumour response between the endoscopic and MRI assessment of tumour response	To evaluate the concordance between the endoscopic and MRI assessment of tumor response	From 8 weeks to 24 weeks after the end of radiotherapy
Secondary	Agreement for grading rectal tumour response between the clinical and endoscopic assessment of tumour response	- To evaluate the concordance between the clinical and endoscopic assessment of tumor response.	From 8 weeks to 24 weeks after the end of radiotherapy
Secondary	Agreement for grading rectal tumour response between the clinical and MRI assessment of tumour response.	To evaluate the concordance between the clinical and MRI assessment of tumor response.	From 8 weeks to 24 weeks after the end of radiotherapy
Secondary	Interobserver agreement for grading rectal tumour response using a digital rectoscope platform	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
Secondary	Rate of changing attitude after using the digital rectoscope platform (intra-observer changing management).	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