Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR
Primary Purpose
Brain Tumor, Cervical Cancer
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-FTX
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Tumor
Eligibility Criteria
Inclusion Criteria:
Glioma Cohort
- Adult (> 18 years old) patients with newly diagnosed or recurrent high grade glioma with newly confirmed pathology (within 1 month)
- Able to provide informed consent
- No contraindications to MRI with gadolinium contrast or 18F-FAZA PET
Cervical Cohort
- Adult (>18 years old) female with newly diagnosed cervical cancer
- Able to provide informed consent
- Receiving surgery, radiotherapy or chemotherapy
- No contraindication to MRI with gadolinium contrast or 18F-FAZA PET
Exclusion Criteria:
Glioma Cohort
- Prior nephrectomy or planned nephrectomy.
- Prior brain radiation within 30 days.
- Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 18F-FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before enrollment after informed consent is obtained. The pregnancy test is part of SOC before imaging.
- Lactation should be suspended for at least two days following the administration of 18F-FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
- Subjects with contraindications to the use of 18F-FAZA including confirmed allergy.
- Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET-MRI scanner, because the findings will probably be compromised in image quality with PET-MRI.
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
Cervical Cohort
- Prior nephrectomy or planned nephrectomy.
- Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 18F-FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before enrollment after informed consent is obtained. The pregnancy test is part of SOC before imaging.
- Lactation should be suspended for at least two days following the administration of 18F-FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
- Subjects with contraindications to the use of 18F-FAZA including confirmed allergy.
- Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET-MRI scanner, because the findings will probably be compromised in image quality with PET-MRI and MRI.
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-FTX
Arm Description
The radioactive tracer (FAZA)
Outcomes
Primary Outcome Measures
To correlate the relationship between dynamic MRI (tumor perfusion (DSC) and permeability (DCE)) and dynamic 18F-FAZA PET uptake.
Secondary Outcome Measures
Full Information
NCT ID
NCT05047913
First Posted
September 3, 2021
Last Updated
October 2, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05047913
Brief Title
Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR
Official Title
Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
April 6, 2025 (Anticipated)
Study Completion Date
April 6, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary Objectives To investigate the relationship between dynamic MRI, brain tumor perfusion (DSC) and permeability (DCE), and dynamic 18F-FAZA PET uptake.
Secondary Objectives To investigate the relationship between tumors with greater hypoxia defined by qBOLD and 18F-FAZA PET and pathological features including proportionate necrosis, Ki-67 and IDH mutation status
To investigate the correlation between the hypoxic tumor region delineated using 18F-FAZA PET and qBOLD
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, 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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-FTX
Arm Type
Experimental
Arm Description
The radioactive tracer (FAZA)
Intervention Type
Drug
Intervention Name(s)
18F-FTX
Intervention Description
Given By IV
Primary Outcome Measure Information:
Title
To correlate the relationship between dynamic MRI (tumor perfusion (DSC) and permeability (DCE)) and dynamic 18F-FAZA PET uptake.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Glioma Cohort
Adult (> 18 years old) patients with newly diagnosed or recurrent high grade glioma with newly confirmed pathology (within 1 month)
Able to provide informed consent
No contraindications to MRI with gadolinium contrast or 18F-FAZA PET
Cervical Cohort
Adult (>18 years old) female with newly diagnosed cervical cancer
Able to provide informed consent
Receiving surgery, radiotherapy or chemotherapy
No contraindication to MRI with gadolinium contrast or 18F-FAZA PET
Exclusion Criteria:
Glioma Cohort
Prior nephrectomy or planned nephrectomy.
Prior brain radiation within 30 days.
Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 18F-FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before enrollment after informed consent is obtained. The pregnancy test is part of SOC before imaging.
Lactation should be suspended for at least two days following the administration of 18F-FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
Subjects with contraindications to the use of 18F-FAZA including confirmed allergy.
Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET-MRI scanner, because the findings will probably be compromised in image quality with PET-MRI.
Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
Cervical Cohort
Prior nephrectomy or planned nephrectomy.
Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 18F-FAZA in pregnancy are not known. A urine or serum pregnancy test will be performed before enrollment after informed consent is obtained. The pregnancy test is part of SOC before imaging.
Lactation should be suspended for at least two days following the administration of 18F-FAZA to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman.
Subjects with contraindications to the use of 18F-FAZA including confirmed allergy.
Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET-MRI scanner, because the findings will probably be compromised in image quality with PET-MRI and MRI.
Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Chung
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
M D Anderson Cancer Center
Learn more about this trial
Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR
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