NCT06057831

PET/MRI in Rectal Cancer

18FDG-PET/MRI Imaging in Predicting Pathological Response to Total Neo-adjuvant Therapy in Rectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see which participants have a better treatment response using PET/MRI imaging to study the removed tumor, after they have received a total neoadjuvant therapy (TNT). The treatment choice of long course chemo-radiotherapy treatment will be determined by institutional policy. The researchers will also be looking at whether this study could significantly improve the future management and quality of life of rectal cancer patients.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Total Neo-adjuvant Therapy	* TNT incorporates chemotherapy with concurrent chemoradiotherapy (CRT) in any order. * Radiotherapy includes 5000 cGy/25 fractions over 5 weeks. * Chemotherapy regimen for Concurrent CRT: Capecitabine * Chemotherapy regimens used with TNT are: FOLFIRINOX x 6 cycles, 8-9 courses FOLFOX or 5-6 courses of CAPEOX delivered over 4-6 months. * The chemotherapy regimen or the order of treatment will be decided at the discretion of the patient's medical oncologist
OTHER	18FDG-PET/MRI scan	18FDG-PET/MRI scan within 4 weeks of commencing chemo-radiation and within 1 - 2 weeks before radical rectal cancer surgery.

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-05-01
• Completion: 2030-12-01
• First posted: 2023-09-28
• Last updated: 2025-06-18