PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study
PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study
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.
The primary purpose of this study is to determine the negative predictive value of PET/MRI
 for determining pathological complete response from neoadjuvant chemoradiation.
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