Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.
PRIMARY OBJECTIVES:
I. To test the diagnostic performance of PET- MRI in the staging of preoperative high-grade
rectal cancer patients, defined by T3 stage or higher or N1 stage or higher or presence of
metastasis, that are referred to PET-CT and MRI.
II. To test the diagnostic performance of PET-MRI the follow up of colorectal cancer
patients that are referred to PET-CT with or without a diagnostic MRI request by their
physicians.
SECONDARY OBJECTIVES:
I. To test different attenuation correction MR sequences and novel diagnostic MR sequences.
OUTLINE:
Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Sensitivity for PET-CT and PET-MRI
Calculated with its 95% confidence interval using the standard formulas according to the criterion standard. Continuous variables will be expressed as mean and standard deviation. Comparisons between continuous variables will be performed by using the Student t test. Comparisons between qualitative variables will be performed by using the chi-square test with the Yates' correction or McNemar's test as appropriate.
2 years
No
Raj Paspulati, MD
Principal Investigator
Case Comprehensive Cancer Center
United States: Institutional Review Board
CASE8212
NCT01807117
March 2013
June 2014
Name | Location |
---|---|
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |