18FDG-PET/MRI Imaging in Predicting Pathological Response to Total Neo-adjuvant Therapy in Rectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- AHS Cancer Control Alberta
- Enrollment
- 40
- Primary Endpoint
- The primary endpoint of the study is pathological response (pCR) prediction with PET/MRI.
- Status
- Not yet recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with histologically proven adenocarcinoma of the rectum.
- •Clinical stage 2-3 rectal adenocarcinoma, cT3/4N0/M0 or Tx N1-2/M0, within 16 cm from anal verge (lesion below the sacral promontory).
- •Patients deemed suitable to undergo TNT followed by surgical resection.
- •Male or female ≥ 18 years of age.
- •ECOG/Zubrod status 0-
- •Able and willing to follow instructions and comply with the protocol.
- •Provide written informed consent prior to participation in the study.
- •Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening if there is concern about pregnancy. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal.
- •If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, concerned about pregnancy are not eligible for the study.
- •Females must not be breastfeeding (during treatment and at least 6 months from the last dose).
Exclusion Criteria
- •Patient receiving short course radiotherapy alone for rectal cancer.
- •Patient receiving standard TNT.
- •Patients with metastatic disease.
- •Prior pelvic radiotherapy or chemotherapy.
- •Patients in whom MRI is contra-indicated as per prevailing institutional guidelines (e.g. pacemakers, aneurysm clips, cochlear implant, implanted cardiac defibrillator).
- •Prior or concurrent malignancy (except non-melanomatous skin cancer) unless disease-free for at least 5 years.
- •Inability to lay in supine position for approximately one hour.
- •Nursing or pregnant females.
- •Age \<18 years.
- •Previous and concurrent, experimental, chemotherapy, or radiotherapy treatment for primary rectal carcinoma.
Outcomes
Primary Outcomes
The primary endpoint of the study is pathological response (pCR) prediction with PET/MRI.
Time Frame: Week 29 - Week 31
A 3-point scale will be used on PET/MRI assessment. When PET and MRI are concordant, the score remains unchanged. When MRI or PET are discordant, but one modality is definitive for complete response (e.g., MRI showing low intensity crescent at site of tumor or no uptake is identified on corresponding location on PET), a tumor regression grade (TRG) score of 1 will be assigned.
Correlation between PET/MRI reported pCR and complete(pCR) or incomplete response(non-pCR) to total neoadjuvant therapy determined by final pathology will be defined.
Time Frame: Week 31
The pathologic response to the total neo-adjuvant therapy will be assessed generally using classification of tumor regression grade (TRG) defined by Mandard et al.
Secondary Outcomes
- To evaluate the significance of PET/MRI compared to MRI to predict response to TNT.(Week 29 - Week 31 (1 - 2 weeks before surgery))
- A feasibility study done to evaluate the benefit of using PET/MRI with respect to improved identification of the target and hence target delineation(Week 29 - Week 31 (1 - 2 weeks before surgery))