Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-cell Therapy
NCT ID: NCT04409314
Last Updated: 2023-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
23 participants
OBSERVATIONAL
2020-04-16
2023-08-09
Brief Summary
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Detailed Description
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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 (if available).
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Diagnostic (18F-FAZA PET scan)
Prior to CAR T-cell therapy, patients receive administration of 18F-FAZA IV. Patients will then undergo a vertex-thigh PET scan approximately 2 hours after injection of 18FFAZA lasting 30-45 minutes.
Fluorine F 18-fluoroazomycin Arabinoside
Given IV
Positron Emission Tomography
Undergo PET scan
Interventions
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Fluorine F 18-fluoroazomycin Arabinoside
Given IV
Positron Emission Tomography
Undergo PET scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aggressive lymphoma, including: Diffuse large B-cell lymphoma (DLBCL) (including transformed disease), high-grade B-cell lymphoma, or primary mediastinal B-cell lymphoma
* Multiple myeloma (MM), with imaging within 6 months of enrollment demonstrating \>= 1 plasmacytoma measuring \>= 5 cm along any axis
* Other malignancy with radiographically measurable disease
* 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
* Pregnancy or active lactation
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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C. Babis Andreadis, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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References
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Banerjee R, Wang V, Huang CY, Pandita D, Leonard MK, LaRue S, Ahmadi M, Kaplan L, Ai WZ, Fakhri B, Spinner M, Seshadri MR, Pampaloni MH, Andreadis CB. Hypoxia-specific imaging in patients with lymphoma undergoing CAR-T therapy. Eur J Nucl Med Mol Imaging. 2023 Sep;50(11):3349-3353. doi: 10.1007/s00259-023-06296-z. Epub 2023 Jun 10.
Other Identifiers
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NCI-2020-03216
Identifier Type: REGISTRY
Identifier Source: secondary_id
20921
Identifier Type: -
Identifier Source: org_study_id
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