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NCT Number: NCT06439914

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location status: Recruiting

Location contact

Ammar Sukari, M.D.

SUB_INVESTIGATOR

Anthony F Shields, MD, PhD

SUB_INVESTIGATOR

Dipesh Uprety, M.D.

SUB_INVESTIGATOR

Hirva Mamdani, M.D.

SUB_INVESTIGATOR

Huailei Jiang, PhD

SUB_INVESTIGATOR

Nerissa T Viola, PhD

CONTACT

[email protected]

3135768309

Nerissa T Viola, PhD

PRINCIPAL_INVESTIGATOR

Otto Muzik, PhD

SUB_INVESTIGATOR

Tarik Hadid, MD, MPH, MS

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[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

Other names: Zirconium Zr 89-DFO-emapalumab

Primary outcomes

  1. peak Standard Uptake Value (SUVpeak)

    Time frame: Up to Day 45

    Descriptively summarize at baseline and post-immunotherapy treatments.

  2. mean Standard Uptake Value (SUVmean)

    Time frame: Up to Day 45

    Descriptively summarize at baseline and post-immunotherapy treatments.

  3. maximum Standard Uptake Value (SUVmax)

    Time frame: Up to Day 45

    Descriptively summarize at baseline and post-immunotherapy treatments.

Secondary outcomes

  1. change of SUVpeak

    Time frame: Up to Day 45

    Descriptively summarize the percent change from baseline to post-immunotherapy treatments.

  2. change of SUVmean

    Time frame: Up to Day 45

    Descriptively summarize the percent change from baseline to post-immunotherapy treatments.

  3. change of SUVmax

    Time frame: Up to Day 45

    Descriptively summarize the percent change from baseline to post-immunotherapy treatments.

Other outcomes

  1. change of SUVpeak by PET response

    Time frame: Up to Day 45

    Descriptively summarize the percent change from baseline to post-immunotherapy by PET response

  2. change of SUVmean by PET response

    Time frame: Up to Day 45

    Descriptively summarize the percent change from baseline to post-immunotherapy by PET response

  3. change of SUVmax by PET response

    Time frame: Up to Day 45

    Descriptively summarize the percent change from baseline to post-immunotherapy by PET response

Study contacts

Contact information is provided by the study sponsor or research team.

Nerissa T Viola, PhD

CONTACT

[email protected]

3135768309

Sponsors and collaborators

Lead sponsor

Nerissa T. Viola

Other

Registry information

Official study title

IFN-y PET Imaging: Bench to Bedside

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 3, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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