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

18 Years
Open (Enrolling)
Rectal Carcinoma

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Trial Information

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

- 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

- 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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology

Outcome Time Frame:

4-8 weeks post-chemoradiation

Safety Issue:


Principal Investigator

Joel E Tepper, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill


United States: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

October 2018

Related Keywords:

  • Rectal Carcinoma
  • Carcinoma
  • Rectal Neoplasms



University of North Carolina-Chapel Hill Chapel Hill, North Carolina  27599