First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy
Purpose
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.
Condition
- Non Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental [89Zr]Zr-DFO-emapalumab |
Radiotracer [89Zr]Zr-DFO-emapalumab injection |
|
Recruiting Locations
Detroit, Michigan 48201
More Details
- Status
- Recruiting
- Sponsor
- Nerissa T. Viola
Detailed Description
Participants will be enrolled into the clinical trial once confirmed eligible. Screening activities include, standard of care blood work, medical history and a physical exam. -Within 14 days of starting immunotherapy, participants will complete PET scans 1-2 hours post-tracer administration, again on the day following tracer administration, and 3-5 days after the tracer administration. This sequence may be repeated 25-45 days after the start of treatment with immunotherapy for a total of two tracer injections and up to six PET scans.