PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
Primary Purpose
Stage IA Cervical Cancer, Stage IA1 Cervical Cancer, Stage IA2 Cervical Cancer
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fludeoxyglucose F-18
Gadobutrol
Magnetic Resonance Imaging
Positron Emission Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Stage IA Cervical Cancer
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (PET/MRI)
Arm Description
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assessing the Lymph node involvement by PET/MRI
Will determine the relationship with pathology.
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.
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.
Full Information
NCT ID
NCT04219904
First Posted
December 30, 2019
Last Updated
October 17, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04219904
Brief Title
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
Official Title
Evaluation of Resectable Cervical Carcinoma With PET/MRI
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 7, 2018 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (PET/MRI)
Arm Type
Experimental
Arm Description
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
Intervention Type
Other
Intervention Name(s)
Fludeoxyglucose F-18
Other Intervention Name(s)
18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Gadobutrol
Other Intervention Name(s)
BAY86-4875, Gadavist, Gadograf, Gadovist, Protovis, ZK 135079
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo PET/MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/MRI
Primary Outcome Measure Information:
Title
Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)
Description
Both PET/MRI and pathology results will be dichotomized into binary outcomes and the accuracy of PET/MRI will assessed.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Assessing the Lymph node involvement by PET/MRI
Description
Will determine the relationship with pathology.
Time Frame
3 years
Title
Inter-observer variability of PET/MR
Description
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.
Time Frame
3 years
Title
Quantitative imaging parameters of the tumor
Description
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.
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanaz Javadi
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer
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