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NCT06439914 | RECRUITING | Non Small Cell Lung Cancer

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

Nerissa T. Viola

Information provided by (Responsible Party):

Nerissa T. Viola

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.

Condition or disease

Non Small Cell Lung Cancer

Intervention/treatment

[89Zr]Zr-DFO-emapalumab

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 6 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : IFN-y PET Imaging: Bench to Bedside
Actual Study Start Date : 2026-09-25
Estimated Primary Completion Date : 2028-06
Estimated Study Completion Date : 2029-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
    • First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy

    Location Details

    NCT06439914

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, road cancer

    Karmanos Cancer Institute

    Detroit, road cancer, United States, 48201