Clinical Trial: Hybrid PET/MR in the Therapy of Cervical Cancer
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study
Brief Summary: This is a two arm, single center feasibility study of 20 patients with non-metastatic cervical cancer managed with surgery and/or chemoradiation therapy at UNC Hospitals. Subjects will undergo PET/MRI scans before, during (chemoradiation group only), and after treatment.
Detailed Summary: The primary purpose of this study is to evaluate the feasibility of obtaining complete and interpretable hybrid PET/MR images for patients diagnosed with cervical cancer.
Sponsor: UNC Lineberger Comprehensive Cancer Center
Current Primary Outcome: Proportion of patients who successfully complete PET/MR scans at all study time-points [ Time Frame: 2-3 months post-treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Sensitivity of PET/MR for baseline disease assessment [ Time Frame: pre-treatment ]Estimated proportion of subjects with disease (positive pathology or PET/CT) that have positive PET/MR scans.
- Specificity of hybrid PET/MR for baseline disease assessment [ Time Frame: pre-treatment ]Proportion of subjects without disease (negative pathology or PET/CT) that have negative PET/MR scans.
- Accuracy of hybrid PET/MR for baseline disease assessment [ Time Frame: pre-treatment ]Proportion of correct assessments among total population
- Detection of disease with PET/MR at each time point [ Time Frame: pre-treatment to 2-3 months post-treatment ]
Original Secondary Outcome: Same as current
Information By: UNC Lineberger Comprehensive Cancer Center
Dates:
Date Received: December 17, 2012
Date Started: October 2012
Date Completion: May 2018
Last Updated: May 2, 2017
Last Verified: May 2017
