PET/MRI in Rectal Cancer

Sponsor
AHS Cancer Control Alberta
Study ID
NCT06057831
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total Neo-adjuvant Therapy — RADIATION
    * 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
  • 18FDG-PET/MRI scan — OTHER
    18FDG-PET/MRI scan within 4 weeks of commencing chemo-radiation and within 1 - 2 weeks before radical rectal cancer surgery.

Study Details

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.

Key Dates

First listed
Sep 28, 2023
Start date
May 31, 2026
Status verified
Jun 2025
Primary completion
May 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    All patients receive total neo-adjuvant therapy (TNT), depending on institutional policy

Primary Outcome Measure

The primary endpoint of the study is pathological response (pCR) prediction with PET/MRI. [ Time Frame: Week 29 - Week 31 ]

Central Contacts

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