Lumeneye Rectoscope for Assessment on Tumor Response After Total Neoadjuvant Treatment in Rectal Cancer
NCT ID: NCT06189846
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-01-04
2025-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Bordeaux Colorectal Institute Academy
OTHER
Responsible Party
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Principal Investigators
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Quentin DENOST
Role: STUDY_DIRECTOR
Bordeaux Colorectal Institute
Locations
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Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
Bordeaux, , France
Hôpital Européen de Marseille
Marseille, , France
Hôpital Saint-Antoine - APHP
Paris, , France
CHU de ROUEN
Rouen, , France
Humanitas Research Hospital
Milan, , Italy
Amsterdam UMC
Amsterdam, , Netherlands
University Hospital Vall D'Hebron
Barcelona, , Spain
Imperial College London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Antoine CAMERLO
Role: primary
Jérémie LEFEVRE
Role: primary
Jean-Jacques TUECH
Role: primary
Antonino SPINELLI
Role: primary
Roel HOMPES
Role: primary
Eloy ESPIN
Role: primary
James KINROSS
Role: primary
Other Identifiers
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BCIA 2023/02
Identifier Type: -
Identifier Source: org_study_id
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