Hybrid PET/MR in the Therapy of Cervical Cancer
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.
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.
Cervical Squamous Cell Carcinoma
Cervical Adenosquamous Carcinoma
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study|
- Proportion of patients who successfully complete PET/MR scans at all study time-points [ Time Frame: 2-3 months post-treatment ] [ Designated as safety issue: No ]
- Sensitivity of PET/MR for baseline disease assessment [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759355
|Contact: Dorothy Riguera, BSfirstname.lastname@example.org|
|United States, North Carolina|
|University of North Carolina-Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Dorothy Riguera, BS 919-843-5420 email@example.com|
|Principal Investigator: Julia Fielding, MD|
|Sub-Investigator: Ellen Jones, MD,PhD|
|Sub-Investigator: Paola Gehrig, MD|
|Sub-Investigator: Victoria Bae-Jump, MD,PhD|
|Sub-Investigator: Mahesh Varia, MD|
|Sub-Investigator: Amir Khandani, MD|
|Sub-Investigator: William McCartney, MD|
|Sub-Investigator: Nathan Sheets, MD|
|Principal Investigator:||Julia Fielding, MD||University of North Carolina, Chapel Hill|