NCT06439914 First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy
| NCT ID | NCT06439914 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Nerissa T. Viola |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2026-03-09 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Nerissa T Viola, PhD
PRINCIPAL INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Frequently Asked Questions
Who can join the NCT06439914 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06439914 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06439914 currently recruiting?
Yes, NCT06439914 is actively recruiting participants. Contact the research team at violan@karmanos.org for enrollment information.
Where is the NCT06439914 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT06439914 clinical trial?
NCT06439914 is sponsored by Nerissa T. Viola. The principal investigator is Nerissa T Viola, PhD at Barbara Ann Karmanos Cancer Institute. The trial plans to enroll 6 participants.
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