Evaluating PET-MRI for assessing treatment response in advanced rectal cancer
Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Institut de cancérologie Strasbourg Europe · NCT05772481
This study is testing if PET-MRI scans can help doctors see how well treatment is working for people with advanced rectal cancer before they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Institut de cancérologie Strasbourg Europe (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05772481 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of PET-MRI in assessing the response of locally advanced rectal adenocarcinoma to neoadjuvant treatment. It will involve 50 patients and is designed to be the largest pilot study of its kind, performing multiple PET-MRI scans during treatment. The study seeks to identify predictive parameters that can indicate tumor response to chemotherapy and chemoradiotherapy before surgery. By comparing the results of the second PET-MRI scan with the final treatment outcomes, researchers hope to improve the accuracy of treatment response assessments.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically proven locally advanced rectal cancer who are eligible for neoadjuvant chemotherapy and chemoradiotherapy.
Not a fit: Patients with uncontrolled diabetes, contraindications to MRI or PET scans, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of tumor response, potentially improving treatment strategies for patients with rectal cancer.
How similar studies have performed: While this approach is novel in the context of rectal cancer, similar studies using PET-MRI in other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Strasbourg
- Institut de cancérologie Strasbourg Europe — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Manon VOEGELIN
- Email: promotion-rc@icans.eu
- Phone: +33 6 68 33 95 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rectal Cancer