NCT04219904

PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer

Evaluation of Resectable Cervical Carcinoma With PET/MRI

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: 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

• Stage IA Cervical Cancer
• Stage IA1 Cervical Cancer
• Stage IA2 Cervical Cancer
• Stage IB Cervical Cancer
• Stage IB1 Cervical Cancer
• Stage IB2 Cervical Cancer
• Stage IB3 Cervical Cancer

Interventions

Type	Name	Description
OTHER	Fludeoxyglucose F-18	Given IV
DRUG	Gadobutrol	Given IV
PROCEDURE	Magnetic Resonance Imaging	Undergo PET/MRI
PROCEDURE	Positron Emission Tomography	Undergo PET/MRI

Timeline

• Start date: 2018-09-07
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2020-01-07
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study