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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04219904
Other study ID # 2017-0066
Secondary ID NCI-2019-0825520
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date September 7, 2018
Est. completion date September 30, 2025

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 25
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Fludeoxyglucose F-18
Given IV
Drug:
Gadobutrol
Given IV
Procedure:
Magnetic Resonance Imaging
Undergo PET/MRI
Positron Emission Tomography
Undergo PET/MRI

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI) Both PET/MRI and pathology results will be dichotomized into binary outcomes and the accuracy of PET/MRI will assessed. 3 years
Secondary Assessing the Lymph node involvement by PET/MRI Will determine the relationship with pathology. 3 years
Secondary Inter-observer variability of PET/MR 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
Secondary Quantitative imaging parameters of the tumor 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
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