First-in-human Interferon-γ PET imaging to monitor immunotherapy response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human trial uses an interferon-γ–targeted PET tracer ([89Zr]Zr-DFO-emapalumab) to image lesions and changes after starting standard-of-care immunotherapy in treatment-naïve NSCLC patients. Participants undergo baseline imaging and a repeat imaging session about 25–45 days after treatment begins, with each injection followed by PET scans at 1–2 hours, the next day, and 3–5 days to capture tracer kinetics. Screening includes standard blood tests, medical history, physical exam, and recent FDG PET; eligible patients must have measurable disease (≥2 cm) and meet lab and body size limits for the scanner. All imaging is done at the sponsoring cancer center with two tracer injections and up to six PET scans per participant.

Why it matters

Who can join: the full rules

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.

Where it's running

• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting

Study contacts

• Principal investigator: Nerissa T Viola, PhD — Barbara Ann Karmanos Cancer Institute
• Study coordinator: Nerissa T Viola, PhD
• Email: violan@karmanos.org
• Phone: 3135768309

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.