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

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Stage IA1 Cervical Cancer; Stage IB Cervical Cancer; Stage IB2 Cervical Cancer; Stage IB1 Cervical Cancer; Stage IA Cervical Cancer; Stage IA2 Cervical Cancer; Stage IB3 Cervical Cancer

Treatments: Procedure: Magnetic Resonance Imaging; Other: Fludeoxyglucose F-18; Drug: Gadobutrol; Procedure: Positron Emission Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04219904

P30CA016672 (U.S. NIH Grant/Contract)

2017-0066 (Other Identifier)

NCI-2019-08255 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Diagnostic (PET/MRI)

Experimental group

Description:

Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.

Treatment:

Procedure: Positron Emission Tomography

Drug: Gadobutrol

Other: Fludeoxyglucose F-18

Procedure: Magnetic Resonance Imaging