Hybrid PET/MR in the Therapy of Cervical Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Surgery 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
Participants will undergo a FDG, gadolinium enhanced PET/MR scan.
Other Names:
|
| Chemoradiation 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
Participants will undergo a FDG, gadolinium enhanced PET/MR scan.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients who successfully complete PET/MR scans at all study time-points [2-3 months post-treatment]
Secondary Outcome Measures
- Sensitivity of PET/MR for baseline disease assessment [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 [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 [pre-treatment]
Proportion of correct assessments among total population
- Detection of disease with PET/MR at each time point [pre-treatment to 2-3 months post-treatment]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
Sponsors and Collaborators
- UNC Lineberger Comprehensive Cancer Center
Investigators
- Principal Investigator: Jorge Oldan, MD, University of North Carolina, Chapel Hill
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LCCC1221