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

NCT ID: NCT04219904

Last Updated: 2025-11-18

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-07

Study Completion Date

2027-09-30

Brief Summary

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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

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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

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Fludeoxyglucose F-18

Intervention Type OTHER

Given IV

Gadobutrol

Intervention Type DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo PET/MRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/MRI

Interventions

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Fludeoxyglucose F-18

Given IV

Intervention Type OTHER

Gadobutrol

Given IV

Intervention Type DRUG

Magnetic Resonance Imaging

Undergo PET/MRI

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET/MRI

Intervention Type PROCEDURE

Other Intervention Names

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18FDG FDG Fludeoxyglucose (18F) fludeoxyglucose F 18 Fludeoxyglucose F18 Fluorine-18 2-Fluoro-2-deoxy-D-Glucose Fluorodeoxyglucose F18 BAY86-4875 Gadavist Gadograf Gadovist Protovis ZK 135079 Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR Imaging MRI MRI Scan NMR Imaging NMRI nuclear magnetic resonance imaging Medical Imaging, Positron Emission Tomography PET PET scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

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

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-0066

Identifier Type: -

Identifier Source: org_study_id

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