Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-cell Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
- Recurrent Aggressive Non-Hodgkin Lymphoma
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent High Grade B-Cell Lymphoma
- Recurrent Malignant Neoplasm
- Recurrent Plasma Cell Myeloma
- Refractory Aggressive Non-Hodgkin Lymphoma
- Refractory Diffuse Large B Cell Lymphoma
- Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
- Refractory High Grade B-Cell Lymphoma
- Refractory Malignant Neoplasm
- Refractory Plasma Cell Myeloma
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 respo...
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. 2. To correlate pre-therapy fluorine F 18-fluoroazomycin arabinoside (18F-FAZA) uptake with pre-therapy 18Ffluorodeoxyglucose (FDG) positron emission tomography (PET) uptake. OUTLINE: Prior to CAR T-cell therapy, patients receive 18F-FAZA intravenously (IV). Beginning 2 hours after injection, patients undergo PET scan over 30-45 minutes. After completion of study, patients are followed up for up to 6 months after CAR T-cell therapy.
Tracking Information
- NCT #
- NCT04409314
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: C. Babis Andreadis, MD University of California, San Francisco
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