Clinical trial · Observational
Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
NCT05772481CI-TRIAL-00115072TEPIRECrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET-MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adult population with rectal cancer
- interventionNames
- Other: PET-MRI
Primary outcomes (3)
- measure
- Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of metabolic criteria.
- timeFrame
- At the surgery
- description
- The purpose of this study is to determine predictive parameters for response to the first phase of treatment by accurately identifying the characteristics of tumors that have responded or not to chemotherapy and chemoradiotherapy. Metabolic criteria will be measured with the SUVmax values that will be determined on the 4 PET-MRI scans.
- measure
- Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of MRI criteria.
- timeFrame
- At the surgery
- description
- MRI criteria will be measured with the Apparent Diffusion Coefficient (ADC) values that will be determined on the 4 PET-MRI scans.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.