Using MRI to Monitor Treatment Response in Rectal Cancer

Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems

This study is testing if using special MRI scans can help doctors see how well treatment is working for patients with rectal cancer who are getting chemotherapy and radiation.

Quick facts

• Study type: Observational
• Enrollment: 39 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut Paoli-Calmettes (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Los Angeles, California and 1 other locations)
• Trial ID: NCT03961776 on ClinicalTrials.gov

What this trial studies

This study explores the feasibility of utilizing diffusion-weighted imaging (DWI) within a magnetic resonance-guided radiotherapy (MRgRT) system to assess early treatment responses in patients undergoing neoadjuvant chemotherapy and radiation for rectal adenocarcinoma. By monitoring changes in tumor characteristics during treatment, the study aims to identify potential markers that could indicate how well the therapy is working. The approach involves patients receiving MRI-guided radiotherapy while their treatment response is evaluated through on-board DWI sequences.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with histologically confirmed rectal adenocarcinoma who are eligible for neoadjuvant chemotherapy and radiation.

Not a fit: Patients with predominant mucinous components in their tumors or those with contraindications to MRI procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel method for early assessment of treatment effectiveness in rectal cancer, potentially leading to more personalized treatment plans.

How similar studies have performed: While the use of MRI in cancer treatment monitoring is established, the specific application of on-board DWI in this context is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Patient over 18 years old.
2. Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated.
3. Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1
4. Signed consent to participation.
5. For women of childbearing age, effective contraception must also be agreed for the duration of treatment.
6. Affiliation to a social security regimen, or beneficiary of such a regimen.

Exclusion Criteria:

1. Predominant mucinous component on initial MRI, biopsy and / or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs.
2. Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia).
3. Exclusive radiation therapy.
4. Other associated neo-adjuvant treatment.
5. Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure.
6. Contraindications to capecitabine: Severe hepatic impairment, severe renal impairment (creatinine clearance \<30 ml / min),
7. Known deficiency of Dihydropyrimidine dehydrogenase (DPD), known hypersensitivity to 5-FU / capecitabine and / or its excipients.
8. Participation in a protocol with concurrent treatment.
9. Pregnant or likely to be pregnant (without effective contraception) or breastfeeding
10. Person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his / her consent.
11. Impossibility of attending the medical examination of the test for geographical, social or psychological reasons.

Where this trial is running

Los Angeles, California and 1 other locations

• University of California Los Angeles (UCLA) — Los Angeles, California, United States (NOT_YET_RECRUITING)
• Institut Paoli Calmettes — Marseille, Bouches Du Rhone, France (RECRUITING)

Study contacts

• Principal investigator: Marguerite TYRAN, MD — Institut Paoli-Calmettes
• Study coordinator: Dominique GENRE, MD

Conditions: Rectal Adenocarcinoma, Diffusion weighted imaging, Radiation therapy