RecruitingNCT06189846

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

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

Sponsor

Bordeaux Colorectal Institute Academy

Enrollment

100 participants

Start Date

Jan 4, 2024

Study Type

OBSERVATIONAL

Conditions

Rectal Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria9

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).

Interventions

DEVICEInternational 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.