Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Cervix Carcinoma
Conditions
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 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.
Interventions
PROCEDUREFDG PET/MR
Participants will undergo a FDG, gadolinium enhanced PET/MR scan.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who successfully complete PET/MR scans at all study time-points | 2-3 months post-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed