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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Participants undergoing surgical intervention will receive a PET/MR scan prior and following surgery for a total of two (2) scans. |
| |
| Chemoradiation | Participants undergoing chemoradiation intervention will receive a PET/MR scan prior, during, and following chemoradiation for a total of three (3) scans. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG PET/MR | Procedure | Participants will undergo a FDG, gadolinium enhanced PET/MR scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who successfully complete PET/MR scans at all study time-points | 2-3 months post-treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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UNC Hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Oldan, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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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 |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |