New digital scope could help rectal cancer patients avoid surgery
NCT ID NCT06189846
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new digital scope called LUMENEYE to see if it can better measure how much a rectal tumor has shrunk after chemotherapy and radiation. 82 patients who were good candidates for organ preservation were included. The goal was to see if the scope could help doctors decide who can safely skip surgery and keep their rectum.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LUMENEYE rectoscope (a digital endoscope device)
- What this could lead to
- If successful, this could help doctors more accurately decide which rectal cancer patients can safely avoid surgery and preserve their rectum after chemotherapy and radiation.
- What could go wrong
- This is a small, completed observational study (82 people) that only measures how well the device agrees with standard tests. It does not test a new treatment or prove long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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82 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Amsterdam UMC
Amsterdam, Netherlands
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CHU de ROUEN
Rouen, France
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Clinique Tivoli-Ducos - Bordeaux Colorectal Institute
Bordeaux, France
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Humanitas Research Hospital
Milan, Italy
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Hôpital Européen de Marseille
Marseille, France
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Hôpital Saint-Antoine - APHP
Paris, France
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Imperial College London
London, United Kingdom
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University Hospital Vall D'Hebron
Barcelona, Spain
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Other studies related to the condition(s) this trial covers.
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- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?