Recruiting
Phase 1

\[89Zr\]Zr-DFO-Emapalumab

Sponsor:

Nerissa T. Viola

Code:

NCT06439914

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[89Zr]Zr-DFO-emapalumab

Study Details

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.

Conditions

Non Small Cell Lung Cancer

Study ID

NCT06439914

Start date

Mar 9, 2026

Status verified date

Mar, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: [89Zr]Zr-DFO-emapalumab

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

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

Primary outcome measure

  • peak Standard Uptake Value (SUVpeak) [ Time Frame: Up to Day 45 ]
  • mean Standard Uptake Value (SUVmean) [ Time Frame: Up to Day 45 ]
  • maximum Standard Uptake Value (SUVmax) [ Time Frame: Up to Day 45 ]

Central Contacts and Locations

Central contacts

Nerissa T Viola, PhD

3135768309violan@karmanos.org

Locations

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Nerissa T Viola, PhD

3135768309violan@karmanos.org

Principal Investigator:

Nerissa T Viola, PhD

More Information

Sponsor

Nerissa T. Viola

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nerissa T. Viola on 2026-03-11.