MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer
NCT ID: NCT01992861
Last Updated: 2023-06-26
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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TERMINATED
51 participants
OBSERVATIONAL
2014-02-14
2022-01-31
Brief Summary
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Detailed Description
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Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo dynamic contrast-enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and magnetic resonance (MR) spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and fludeoxyglucose F 18 (FDG) PET/computed tomography (CT) at baseline, 2-2.5 weeks, and 4-5 weeks.
After completion of study, patients are followed up at least every 3-6 months for 5 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)
Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo DCE MRI, DW MRI, and MR spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and FDG PET/CT at baseline, 2-2.5 weeks, and 4-5 weeks.
Computed Tomography
Undergo FDG PET/CT
Diffusion Weighted Imaging
Undergo DW MRI
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Fludeoxyglucose F-18
Undergo FDG PET/CT
Magnetic Resonance Spectroscopic Imaging
Undergo MR spectroscopy
Positron Emission Tomography
Undergo FDG PET/CT
Interventions
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Computed Tomography
Undergo FDG PET/CT
Diffusion Weighted Imaging
Undergo DW MRI
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Fludeoxyglucose F-18
Undergo FDG PET/CT
Magnetic Resonance Spectroscopic Imaging
Undergo MR spectroscopy
Positron Emission Tomography
Undergo FDG PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
* Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
* Patients with no prior radiation therapy to the pelvis
* Patients with no contra-indications to magnetic resonance (MR) imaging
* Patients must have adequate renal function: glomerular filtration rate (GFR) \> 30 mL/min/1.73 m\^2; for the test-retest sub-study MRI, patients must have a GFR of \> 60 mL/min/1.73m\^2
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
* Patients who have received any prior pelvic radiation therapy in the area of the tumor that precludes the delivery of a curative dose of pelvic radiation
* Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR \< 30)
* Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up
* Life expectancy of less than 6 months
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health (NIH)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Simon Lo
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
University of Toronto
Toronto, Ontario, Canada
University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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NCI-2013-01935
Identifier Type: REGISTRY
Identifier Source: secondary_id
8118
Identifier Type: OTHER
Identifier Source: secondary_id
RG3114003
Identifier Type: OTHER
Identifier Source: secondary_id
8118
Identifier Type: -
Identifier Source: org_study_id
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