First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy

Nerissa T. Viola

Status and phase

Enrolling

Phase 1

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: [89Zr]Zr-DFO-emapalumab

Study type

Interventional

Funder types

Other

Identifiers

NCT06439914

2023-092

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.