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About
This study evaluates whether tumors present in patients with cancer who are planned to get CAR T-cells have low amounts of oxygen (hypoxia). PET scans may be used to check the amounts of oxygen within areas of cancer with a special radioactive tracer called FAZA that specifically looks for areas of low oxygen. This study is being done to help researchers determine how the amount of oxygen within areas of cancer affect how well CAR T-cells kill cancer cells.
Full description
PRIMARY OBJECTIVE:
I. To evaluate the incidence of intratumoral hypoxia in patients with relapsed or refractory (R/R) malignancies before treatment with chimeric antigen receptor (CAR) T-cell therapy.
SECONDARY OBJECTIVE:
I. To evaluate the association between intratumoral hypoxia and clinical responses to CAR T-cell therapy.
EXPLORATORY OBJECTIVES:
I. To correlate intratumoral hypoxia with markers of CAR T-cell activity and toxicity.
OUTLINE:
Prior to CAR T-cell therapy, patients receive 18F-FAZA intravenously (IV). Beginning 2 hours after injection, patients undergo a single PET scan. Patients are followed for up to 6 months after CAR T-cell therapy.
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Inclusion criteria
Histologically confirmed diagnosis of:
R/R disease with planned receipt of CAR T-cell therapy at University of California, San Francisco (UCSF), either through an Food and Drug Administration-approved CAR construct or through a separate interventional clinical trial
Ability to provide informed consent prior to study entry
Exclusion criteria
23 participants in 1 patient group
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Central trial contact
Morgan Tate
Data sourced from clinicaltrials.gov
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