Hybrid PET/MR in the Therapy of Cervical Cancer

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study

Conditions
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Cervix Carcinoma, Cervical Squamous Cell Carcinoma, Cervical Adenosquamous Carcinoma

Intervention / Treatment
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* Procedure: FDG PET/MR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Biopsy-proven, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix Clinically visible lesion at least FIGO stage Ib or AJCC 7th edition T1b Scheduled to undergo standard of care PET/CT for baseline assessment of disease Anticipated to be eligible for curative intent therapy (surgery of chemoradiation therapy) as determined by the patient's primary oncologist If female of child-bearing potential, negative serum or urine pregnancy test ≤ 7 dats prior to first PET/MRI Informed consent reviewed and signed Exclusion Criteria: History of sever reaction to contrast-enhanced CT scan Inability to tolerate MRI (e.g., inability to lie flat > 1 hour) Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes Poorly controlled diabetes mellitus Creatinine > 1.4 mg/dL or GFR < 30 mL/min Body Mass Index (BMI) > 35 Active vaginal bleeding requiring packing and emergent radiation therapy Pregnant or lactating female History of a prior malignancy within past 5 years, unless disease free for ≥ 3 years Substance abuse, medical, psychological, or social conditions that may interfere with study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery<br>Participants undergoing surgical intervention will receive a PET/MR scan prior and following surgery for a total of two (2) scans. | Procedure: FDG PET/MR<br>* Participants will undergo a FDG, gadolinium enhanced PET/MR scan.<br>* Other names: FDG Positron Emission Tomography/Magnetic Resonance Scan;|
| Chemoradiation<br>Participants undergoing chemoradiation intervention will receive a PET/MR scan prior, during, and following chemoradiation for a total of three (3) scans. | Procedure: FDG PET/MR<br>* Participants will undergo a FDG, gadolinium enhanced PET/MR scan.<br>* Other names: FDG Positron Emission Tomography/Magnetic Resonance Scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who successfully complete PET/MR scans at all study time-points |  | 2-3 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of PET/MR for baseline disease assessment | Estimated proportion of subjects with disease (positive pathology or PET/CT) that have positive PET/MR scans. | pre-treatment | 
| Specificity of hybrid PET/MR for baseline disease assessment | Proportion of subjects without disease (negative pathology or PET/CT) that have negative PET/MR scans. | pre-treatment | 
| Accuracy of hybrid PET/MR for baseline disease assessment | Proportion of correct assessments among total population | pre-treatment | 
| Detection of disease with PET/MR at each time point |  | pre-treatment to 2-3 months post-treatment |