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
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
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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-
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.
|
Given IV
Other Names:
Undergo PET/MRI
Other Names:
Undergo PET/MRI
Other Names:
Given IV
Other Names:
|
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
Collaborators
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
- Urogenital Diseases
- Genital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Neoplasms
- Uterine Cervical Neoplasms
- Investigative Techniques
- Carbohydrates
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Deoxyglucose
- Deoxy Sugars
- Fluorodeoxyglucose F18
- Magnetic Resonance Spectroscopy
- gadobutrol
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.