Clinical trial · Observational
Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-cell Therapy
Pilot Study of Hypoxia-Specific Imaging to Predict Outcomes of Chimeric Antigen Receptor T-Cell Therapy
NCT04409314CI-TRIAL-00068916completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Aggressive Non-Hodgkin Lymphoma | Aggressive Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Recurrent High Grade B-Cell Lymphoma | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Recurrent Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Plasma Cell Myeloma | Multiple Myeloma | CURATED_BROADER | 0.80 |
| Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma | — | UNRESOLVED | — |
| Refractory Aggressive Non-Hodgkin Lymphoma | Aggressive Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorine F 18-fluoroazomycin Arabinoside | Drug | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Diagnostic (18F-FAZA PET scan)
- description
- 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.
- interventionNames
- Drug: Fluorine F 18-fluoroazomycin Arabinoside
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- Proportion of fluorine F 18-fluoroazomycin arabinoside (18F-FAZA) positron emission tomography (PET) scans with positive hypoxic volume (HV)
- timeFrame
- After completion of one-time 18F-FAZA PET scan, 1 day
- description
- Will calculate the uniformly minimum-variance unbiased estimator, p-value and 95% confidence interval (CI) for the response rates.
Secondary outcomes (1)
- measure
- Overall response (OR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of: * 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: * Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures * Pregnancy or active lactation
References
Publications (1)
- DERIVEDBanerjee 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. PMID 37300573