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RECRUITING

NCT05772481

Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

Sponsor: Centre Paul Strauss

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2023-05-19

Completion Date

2026-09-18

Last Updated

2026-06-05

Healthy Volunteers

Conditions

Rectal Cancer

Interventions

OTHER

PET-MRI

Each patient will have a pre-treatment PET-MRI (PET-MRI 1) within 21 days before the start of treatment. Induction chemotherapy may be performed at another center than the investigating center. After 3 cycles of induction chemotherapy and before the 4th cycle, a second PET MRI (PET MRI 2) will be performed. In patients who have received less than 3 cycles of induction chemotherapy, this mid-therapy PET-MRI will not be performed. A 3rd PET-MRI will be performed prior to radiation therapy (PET-MRI 3). A final MRI PET (MRI PET 4) will take place before surgery. A total of 4 PET MRI scans will be performed.

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 * Adequate hematologic function * Adequate liver function * 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) * Hypofractionated radiotherapy according to the Swedish protocol (25 Gy in 5 fractions) * 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

Locations (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, France