Stage IB Cervical Cancer Clinical Trial
Official title:
Evaluation of Resectable Cervical Carcinoma With PET/MRI
Verified date | May 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
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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