PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
NCT ID: NCT04219904
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
EARLY_PHASE1
25 participants
INTERVENTIONAL
2018-09-07
2027-09-30
Brief Summary
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Detailed Description
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I. To assess depth of cervical invasion with positron emission tomography/magnetic resonance imaging (PET/MRI) in patients with cervical cancer in clinical Federation of Gynecology and Obstetrics (FIGO) staging undergoing evaluation for surgical resection and correlate with pathology.
SECONDARY OBJECTIVES:
I. To correlate lymph node involvement on PET/MRI with pathology. II. To assess the inter-observer variability in the interpretation of PET/MRI. III. To correlate the quantitative imaging parameters of the tumor, such as the volumetric size, blood oxygen level dependent (BOLD), intravoxel incoherent motion (IVIM) analysis, apparent diffusion coefficient (ADC), diffusion tensor imaging (DTI), dynamic contrast-enhanced (DCE), metabolic tumor volume (MTV), total lesion glycolysis (TLG), standardized uptake value (SUV) and the glucose metabolic rate (GMR) with lymphovascular space invasion (LVSI) and tumor grade on surgical pathology.
OUTLINE:
Patients receive fludeoxyglucose F-18 and gadobutrol intravenously (IV) over 1 minute and undergo PET/MRI over 90-120 minutes.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (PET/MRI)
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
Fludeoxyglucose F-18
Given IV
Gadobutrol
Given IV
Magnetic Resonance Imaging
Undergo PET/MRI
Positron Emission Tomography
Undergo PET/MRI
Interventions
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Fludeoxyglucose F-18
Given IV
Gadobutrol
Given IV
Magnetic Resonance Imaging
Undergo PET/MRI
Positron Emission Tomography
Undergo PET/MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No contraindications to MRI
* Patients undergoing surgical procedure at MD Anderson
* Suspected cervical cancer
Exclusion Criteria
* Glomerular filtration rate (GFR) \< 30
* Pregnant patients
* Patients with history of previous radiation
* Patients with previous surgery for cervical cancer, unless residual tumor noted on physical exam
* Patients with endometrial cancer extending to the cervix
* Allergic reaction to gadolinium based contrast
* Body weight of greater than 450 (181.4 kg)
* Patients requiring general sedation
* Extremely claustrophobic patients
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sanaz Javadi
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-08255
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0066
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0066
Identifier Type: -
Identifier Source: org_study_id
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