Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Centre Paul Strauss
50 participants
May 19, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria21
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05772481