First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy
Part of paid clinical trials in Detroit, Michigan.
- Sponsor
- Nerissa T. Viola
- Study ID
- NCT06439914
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- [89Zr]Zr-DFO-emapalumab — DRUGRadiotracer \[89Zr\]Zr-DFO-emapalumab administration followed by 3 PET Scans (day 0, day 1 and day 3-5) within 14 days of starting immunotherapy and repeated once 25-45 days after immunotherapy started
Study Details
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.
Key Dates
- Start date
- Mar 9, 2026
- Status verified
- Mar 2026
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 6 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: [89Zr]Zr-DFO-emapalumabRadiotracer \[89Zr\]Zr-DFO-emapalumab injection
Primary Outcome Measure
peak Standard Uptake Value (SUVpeak) [ Time Frame: Up to Day 45 ]
Central Contacts
- Nerissa T Viola, PhD3135768309
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Nerissa T Viola, PhD (PRINCIPAL_INVESTIGATOR) Anthony F Shields, MD, PhD (SUB_INVESTIGATOR) Hirva Mamdani, M.D. (SUB_INVESTIGATOR) Dipesh Uprety, M.D. (SUB_INVESTIGATOR) Ammar Sukari, M.D. (SUB_INVESTIGATOR) Tarik Hadid, MD, MPH, MS (SUB_INVESTIGATOR) Otto Muzik, PhD (SUB_INVESTIGATOR) Huailei Jiang, PhD (SUB_INVESTIGATOR) |
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