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

NCT ID: NCT06439914

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-25
• Study Completion Date: 2029-06-30

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.

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[89Zr]Zr-DFO-emapalumab

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

Group Type: EXPERIMENTAL

[89Zr]Zr-DFO-emapalumab

Intervention Type: 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

Interventions

[89Zr]Zr-DFO-emapalumab

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

Intervention Type: DRUG

Other Intervention Names

Zirconium Zr 89-DFO-emapalumab

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nerissa T. Viola

OTHER

Sponsor Role: lead

Responsible Party

Nerissa T. Viola

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nerissa T Viola, PhD

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nerissa T Viola, PhD

Role: CONTACT

violan@karmanos.org

3135768309

Facility Contacts

Nerissa T Viola, PhD

Role: primary

violan@karmanos.org

3135768309

Other Identifiers

2023-092

Identifier Type: -

Identifier Source: org_study_id