PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study

Study Overview
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Brief Summary
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This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery.

Detailed Description
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The primary purpose of this study is to determine the negative predictive value of PET/MRI for determining pathological complete response from neoadjuvant chemoradiation.

Official Title
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PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.

Conditions
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Rectal Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low-lying, low- to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+ Negative workup for distant disease > 18 years of age Pre-treatment workup completed including: history and physical CT or MRI of the abdomen and pelvis endoscopic tumor evaluation (biopsy, blood work to assess CEA and hematopoietic, renal and liver function) if female of child-bearing age, negative pregnancy test Recommendation to undergo preoperative concurrent chemoradiation, as determined by the treating physician Informed consent reviewed and signed Exclusion Criteria: Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease Hemoglobin ≤ 10.0 g/dL (transfusion allowed to achieve or maintain levels) ANC ≤ 1,500/cubic mm³ Platelet count ≤ 100,000/mm³ ALT and AST ≥ 2.5 times upper level of normal (ULN) Alkaline phosphatase ≥ 2.5 times ULN Total bilirubin ≥ 1.5 times ULN Creatinine clearance < 50 mL/min Creatinine ≥ 1.5 times ULN Not deemed a candidate for concurrent preoperative chemoradiation for social reasons, such as psychiatric illness Not deemed a surgical candidate Currently active second malignancy, except non-melanoma skin cancer, non-invasive bladder cancer, low risk adenocarcinoma of the prostate and carcinoma in situ of the cervix Previous pelvic radiation therapy History of severe reaction to gadolinium Inability to tolerate MRI (e.g., inability to lie flat for > 1 hour) Presence of a pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes Body Mass Index (BMI) > 35 Pregnant or lactating female

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology |  | 4-8 weeks post-chemoradiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence-free survival |  | 5 years | 
| Disease-specific survival |  | 5 years | 
| Overall survival |  | 5 years |