This phase I trial tests whether [89Zr]Zr-DFO-emapalumab can be used as an interferon-gamma (IFN-g) positron emission tomography (PET)/computed tomography (CT) imaging agent to detect lesions and monitor response to treatment in patients with non-small cell lung cancer (NSCLC). IFN-g has been an appealing target for evaluating immune response in cancer chemotherapy. [89Zr]Zr-DFO-emapalumab is an imaging tracer that is used to visualize tumors using a PET scan. A PET scan uses radioactive material injected into the blood to show the internal workings of the body. A CT scan uses x-rays and a computer to produce a 3-dimensional image of the body. Combining the two scans may help doctors better understand the extent and the exact location of disease. Diagnostic procedures, such as [89Zr]Zr-DFO-emapalumab, may help detect tumors and predict treatment response in patients with NSCLC.
Additional locations may be listed on ClinicalTrials.gov for NCT06439914.
Locations matching your search criteria
United States
Michigan
Detroit
Wayne State University/Karmanos Cancer InstituteStatus: Active
Contact: Nerissa Viola
Phone: 313-576-8309
PRIMARY OBJECTIVE:
I. To descriptively summarize the tracer pharmacokinetic (PK) parameters, including peak, mean, and maximum standard uptake value (SUVpeak, SUVmean, and SUVmax), both at baseline and following immunotherapy treatments.
SECONDARY OBJECTIVE:
I. To descriptively summarize the PET radiotracer uptake in terms of the percentage change in SUVpeak, SUVmean, and SUVmax from baseline to after immunotherapy treatments.
EXPLORATORY OBJECTIVE:
I. To descriptively examine the association between PET radiotracer uptake (percentage change in SUVpeak, SUVmean, and SUVmax) and PET response, assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 through CT and magnetic resonance imaging (MRI) evaluations, with a focus on the five largest lesions.
OUTLINE:
Patients receive [89Zr]Zr-DFO-emapalumab intravenously (IV) and undergo up to 3 PET/CT scans over 60-90 minutes post-injection on days 1 and 3-5. Depending on the results of the first imaging session, patients may receive additional [89Zr]Zr-DFO-emapalumab IV and undergo repeat PET/CT scans 25-45 days post-immunotherapy per standard of care (SOC).
Lead OrganizationWayne State University/Karmanos Cancer Institute
Principal InvestigatorNerissa Viola