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