PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
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
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Early Phase 1
- Age range
- 18 years - Not specified
- Sex eligible
- Female
- Healthy volunteers
- Not accepted
- Participants
- 25 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Diagnostic (PET/MRI)
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
Other: Fludeoxyglucose F-18 · Drug: Gadobutrol · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography
Fludeoxyglucose F-18 OTHER
Given IV
Gadobutrol DRUG
Given IV
Magnetic Resonance Imaging PROCEDURE
Undergo PET/MRI
Positron Emission Tomography PROCEDURE
Undergo PET/MRI
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Secondary measures
Assessing the Lymph node involvement by PET/MRI
Time frame: 3 years
Will determine the relationship with pathology.
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.
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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
M D Anderson Cancer CenterHouston, Texas, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- M.D. Anderson Cancer Center
- Study start
- Sep 7, 2018 Actual
- Primary completion
- Sep 30, 2027 Estimated
- Study completion
- Sep 30, 2027 Estimated
- First posted
- Jan 7, 2020 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Evaluation of Resectable Cervical Carcinoma With PET/MRI
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026