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First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy
RECRUITINGPhase 1Sponsored by Nerissa T. Viola
Actively Recruiting
PhasePhase 1
SponsorNerissa T. Viola
Started2026-09-25
Est. completion2028-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06439914
Summary
The goal of this clinical trial is to investigate the use of \[89Zr\]Zr-DFO-emapalumab as an IFN-γ PET imaging agent to detect lesions and response to therapy among treatment-naïve non-small cell lung cancer (NSCLC) patients. PET scans following the imaging agent will be completed prior to and about 30 days after starting immunotherapy.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion * Prior histologic or cytologic diagnosis of non-small cell lung cancer. * FDG PET done within 2 months of the baseline imaging, as part of standard-of-care. * measurable disease by RECIST 1.1 with at least one lesion of at least 2 cm in a region of the body that can be imaged by PET (e.g.,outside of the liver) * must be able to lie still for the tests. Their girth and weight must be suitable to enter the gantry, which varies per tomograph. * must be \>18 years old. * Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the cancer center. * Physical exam, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST, and ALT) must be done within 28 days prior to PET imaging Exclusion * No prior immunotherapy for current stage of NSCLC (Non Small Cell Lung Cancer). Immunotherapy in neoadjuvant or adjuvant setting and have recurrence at least 12 months following completion of immunotherapy are eligible after discussion with the principle investigator. * Pregnant or breast feeding individuals.
Conditions3
CancerLung CancerNon Small Cell Lung Cancer
Locations1 site
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Actively Recruiting
PhasePhase 1
SponsorNerissa T. Viola
Started2026-09-25
Est. completion2028-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06439914