Clinical trial NCT06439914: First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy
Official title: IFN-y PET Imaging: Bench to Bedside
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: peak Standard Uptake Value (SUVpeak)
timeFrame: Up to Day 45
measure: mean Standard Uptake Value (SUVmean)
timeFrame: Up to Day 45
measure: maximum Standard Uptake Value (SUVmax)
timeFrame: Up to Day 45
Secondary outcomes:
measure: change of SUVpeak
timeFrame: Up to Day 45
measure: change of SUVmean
timeFrame: Up to Day 45
measure: change of SUVmax
timeFrame: Up to Day 45
Other outcomes:
measure: change of SUVpeak by PET response
timeFrame: Up to Day 45
measure: change of SUVmean by PET response
timeFrame: Up to Day 45
measure: change of SUVmax by PET response
timeFrame: Up to Day 45
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Nerissa T Viola, PhD
role: PRINCIPAL_INVESTIGATOR
References: