NCT05772481Recruiting
Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
With 50 patients included, this trial would be the largest pilot study evaluating the value of MRI PET in locally advanced rectal cancer. On the other hand, it would be the only pilot study performing several MRI PET during neoadjuvant treatment. Presumably, the response assessed at the 2nd MRI PET (before cycle 4 or induction chemotherapy) would be predictive of the overall response at the end of neoadjuvant treatment. Then, it would be possible to predict precociously the tumor response.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 8 Feb 2023
- Start date
- 19 May 2023
- Primary completion date
- 18 Sept 2026
- Lead sponsor
- Centre Paul Strauss
- Diseases
- Colorectal cancer
- NCT number
- NCT05772481
What you commit to
- Study type: Observational
- Planned participants: 50
- From 19 May 2023 to the primary completion date, 18 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to surgery
- Contraindication to chemotherapy
- Patient enrolled in another clinical trial testing an investigational agent
Other illness
- Subject with Uncontrolled diabetes
- History of pelvic radiotherapy
- History of major co-morbidity that may prevent treatment and no active infection (HIV or chronic hepatitis B or C)
- History of known Gilbert's disease
- Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
- Medical history of angina or myocardial infarction.
- Active progressive infection or any other serious medical condition that could compromise the administration of the treatment
- Other concurrent cancer, or medical history of cancer other than treated in situ cervical carcinoma or basal cell carcinoma or squamous cell carcinoma
- Any psychological, familial, sociological or geographic condition that may interfere with the study protocol or follow-up schedule
Lab values
- Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
Other
- Contraindication to MRI
- Contraindication to PET scan
- Colloid (mucinous) adenocarcinoma
- Presence of distant metastases
- Contraindication to 5-FluoroUracil (FU), oxaliplatin or irinotecan
- Patient with known UGT1A1 genotype
- Pregnant or breastfeeding woman
- Persons deprived of their freedom or under guardianship or incapable of giving consent
Who the study is looking for
- World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) 0 to 2
- Histologically proven rectal cancer
- clinical tumor classification (cT) : cT3 - cT4 or all T / N+ / M0
- Tumor resectable or considered resectable after chemoradiotherapy
- Decision chemotherapy followed by neoadjuvant chemoradiotherapy decided at the organ Multidisciplinary Meeting
- Absence of distant metastases
- Adequate contraception for women of childbearing potential
- Free, signed and informed consent
- For women of childbearing potential : negative pregnancy test
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.