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

May 18, 2026 updated by: M.D. Anderson Cancer Center

Evaluation of Resectable Cervical Carcinoma With PET/MRI

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (PET/MRI)
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
Drug: Gadobutrol
Given IV
Other Names:
  • BAY86-4875
  • Gadavist
  • Gadograf
  • Gadovist
  • Protovis
  • ZK 135079
Procedure: Magnetic Resonance Imaging
Undergo PET/MRI
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • nuclear magnetic resonance imaging
Procedure: Positron Emission Tomography
Undergo PET/MRI
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PET scan
Other: Fludeoxyglucose F-18
Given IV
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose (18F)
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)
Time Frame: 3 years
Both PET/MRI and pathology results will be dichotomized into binary outcomes and the accuracy of PET/MRI will assessed.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the Lymph node involvement by PET/MRI
Time Frame: 3 years
Will determine the relationship with pathology.
3 years
Inter-observer variability of PET/MR
Time Frame: 3 years
A PET report for clinical use will be generated by a radiologist with appropriate training and credentialing to read PET images. A separate MRI report for clinical use will be generated by a radiologist with appropriate training and credentialing to read MRI. Subsequently, PET/MR images will be evaluated by two radiologists who have appropriate training to read both PET and MRI and 2 research reports will be generated. Inter-observer variability of PET/MRI will be calculated using Cohen's kappa coefficient.
3 years
Quantitative imaging parameters of the tumor
Time Frame: 3 years
Correlate the quantitative imaging parameters of the tumor, such as the volumetric size, blood oxygen level-dependent (BOLD), apparent diffusion coefficient (ADC), IVIM analysis, diffusion tensor imaging (DTI), dynamic contrast-enhanced (DCE), MTV, TLG, standardized uptake value (SUV) and GMR with LVSI and tumor grade on surgical pathology which serves as gold standard. Two-sample t-test or analysis of variance (ANOVA) will be used for comparing the group means between LVSI positive/negative groups and among tumor grades and types. Other statistical analysis will be carried out as appropriate.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Sanaz Javadi, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2018

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

January 4, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0066 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2019-08255 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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