Brain Tumor, Cervical Cancer
Conditions
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
Interventions
DRUG18F-FTX
Given By IV
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To correlate the relationship between dynamic MRI (tumor perfusion (DSC) and permeability (DCE)) and dynamic 18F-FAZA PET uptake. | through study completion, an average of 1 year |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCaroline Chung
M.D. Anderson Cancer Center
Outcome results
None listed