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 — DRUG
    Radiotracer \[89Zr\]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-emapalumab
    Radiotracer \[89Zr\]Zr-DFO-emapalumab injection

Primary Outcome Measure

peak Standard Uptake Value (SUVpeak) [ Time Frame: Up to Day 45 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201
Nerissa T Viola, PhD
3135768309
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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