PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT04219904|
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Fludeoxyglucose F-18 Drug: Gadobutrol Procedure: Magnetic Resonance Imaging Procedure: Positron Emission Tomography||Early Phase 1|
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.
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.
Patients receive fludeoxyglucose F-18 and gadobutrol intravenously (IV) over 1 minute and undergo PET/MRI over 90-120 minutes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Resectable Cervical Carcinoma With PET/MRI|
|Actual Study Start Date :||September 7, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: 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
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219904
|Contact: Sanaz Javadifirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Sanaz Javadi 713-563-7665|
|Principal Investigator: Sanaz Javadi|
|Principal Investigator:||Sanaz Javadi||M.D. Anderson Cancer Center|