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Clinical trial

Evaluation of Resectable Cervical Carcinoma With PET/MRI

ID
Name
2017-0066
Description
This trial studies how well positron emission tomography/magnetic resonance imaging (PET/MRI) scan works in checking patients with stage IA1-IB3 cervical cancer that can be removed by surgery (resectable). PET/MRI scan may help doctors learn more about the spread of the disease.
Trial arms
Trial start
2018-09-07
Estimated PCD
2025-09-30
Trial end
2025-09-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Fludeoxyglucose F-18
Given IV
Arms:
Diagnostic (PET/MRI)
Other names:
18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Gadobutrol
Given IV
Arms:
Diagnostic (PET/MRI)
Other names:
BAY86-4875, Gadavist, Gadograf, Gadovist, Protovis, ZK 135079
Magnetic Resonance Imaging
Undergo PET/MRI
Arms:
Diagnostic (PET/MRI)
Other names:
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging
Positron Emission Tomography
Undergo PET/MRI
Arms:
Diagnostic (PET/MRI)
Other names:
Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Size
25
Primary endpoint
Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)
3 years
Eligibility criteria
Inclusion Criteria: * All patients with suspected clinical stage IA1-IB3 cervical cancer except patients with tumors \> 4 cm * No contraindications to MRI * Patients undergoing surgical procedure at MD Anderson * Suspected cervical cancer Exclusion Criteria: * Patients who have contraindication to MRI * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}
Updated at
2024-05-16

1 organization

1 product

4 indications

Organization
M.D. Anderson Cancer Center
Product
Gadobutrol
Indication
Cervical Cancer
Indication
Stage IA1 Cervical Cancer
Indication
Stage IA2 Cervical Cancer
Indication
Stage IB3 Cervical Cancer