Hybrid PET/MR in the Therapy of Cervical Cancer
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ClinicalTrials.gov Identifier: NCT01759355 |
Recruitment Status :
Completed
First Posted : January 3, 2013
Last Update Posted : December 3, 2021
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Condition or disease | Intervention/treatment |
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Cervix Carcinoma Cervical Squamous Cell Carcinoma Cervical Adenosquamous Carcinoma | Procedure: FDG PET/MR |
Study Type : | Observational |
Actual Enrollment : | 18 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study |
Actual Study Start Date : | October 2012 |
Actual Primary Completion Date : | May 28, 2020 |
Actual Study Completion Date : | May 28, 2020 |

Group/Cohort | Intervention/treatment |
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Surgery
Participants undergoing surgical intervention will receive a PET/MR scan prior and following surgery for a total of two (2) scans.
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Procedure: FDG PET/MR
Participants will undergo a FDG, gadolinium enhanced PET/MR scan.
Other Name: FDG Positron Emission Tomography/Magnetic Resonance Scan |
Chemoradiation
Participants undergoing chemoradiation intervention will receive a PET/MR scan prior, during, and following chemoradiation for a total of three (3) scans.
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Procedure: FDG PET/MR
Participants will undergo a FDG, gadolinium enhanced PET/MR scan.
Other Name: FDG Positron Emission Tomography/Magnetic Resonance Scan |
- Proportion of patients who successfully complete PET/MR scans at all study time-points [ Time Frame: 2-3 months post-treatment ]
- Sensitivity of PET/MR for baseline disease assessment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: pre-treatment ]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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759355
United States, North Carolina | |
University of North Carolina-Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Jorge Oldan, MD | University of North Carolina, Chapel Hill |
Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT01759355 |
Other Study ID Numbers: |
LCCC1221 |
First Posted: | January 3, 2013 Key Record Dates |
Last Update Posted: | December 3, 2021 |
Last Verified: | December 2021 |
Carcinoma Uterine Cervical Neoplasms Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms |
Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Neoplasms, Complex and Mixed |