NCT05772481 Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
| NCT ID | NCT05772481 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Paul Strauss |
| Condition | Rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-05-19 |
| Primary Completion | 2026-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-05-19 with a primary completion date of 2026-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Subject with Uncontrolled diabetes * Contraindication to surgery * Contraindication to MRI * Contraindication to PET scan * Contraindication to chemotherapy * History of pelvic radiotherapy * History of major co-morbidity that may prevent treatment and no active infection (HIV or chronic hepatitis B or C) * Colloid (mucinous) adenocarcinoma * Presence of distant metastases * Contraindication to 5-FluoroUracil (FU), oxaliplatin or irinotecan * History of known Gilbert's disease * Patient with known UGT1A1 genotype * Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency * 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 * Patient enrolled in another clinical trial testing an investigational agent * Pregnant or breastfeeding woman * Persons deprived of their freedom or under guardianship or incapable of giving consent * Any psychological, familial, sociological or geographic condition that may interfere with the study protocol or follow-up schedule
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05772481 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05772481 currently recruiting?
Yes, NCT05772481 is actively recruiting participants. Contact the research team at promotion-rc@icans.eu for enrollment information.
Where is the NCT05772481 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT05772481 clinical trial?
NCT05772481 is sponsored by Centre Paul Strauss. The trial plans to enroll 50 participants.
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