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

Non Small Cell Lung Cancer Clinical Trial

Official title:

IFN-y PET Imaging: Bench to Bedside

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439914
• Other study ID #: 2023-092
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: Nerissa T Viola, PhD
• Phone: 3135768309
• Email: violan[@]karmanos.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• [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

Locations

Country	Name	City	State
United States	Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Nerissa T. Viola

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change of SUVpeak by PET response	Descriptively summarize the percent change from baseline to post-immunotherapy by PET response	Up to Day 45
Other	change of SUVmean by PET response	Descriptively summarize the percent change from baseline to post-immunotherapy by PET response	Up to Day 45
Other	change of SUVmax by PET response	Descriptively summarize the percent change from baseline to post-immunotherapy by PET response	Up to Day 45
Primary	peak Standard Uptake Value (SUVpeak)	Descriptively summarize at baseline and post-immunotherapy treatments.	Up to Day 45
Primary	mean Standard Uptake Value (SUVmean)	Descriptively summarize at baseline and post-immunotherapy treatments.	Up to Day 45
Primary	maximum Standard Uptake Value (SUVmax)	Descriptively summarize at baseline and post-immunotherapy treatments.	Up to Day 45
Secondary	change of SUVpeak	Descriptively summarize the percent change from baseline to post-immunotherapy treatments.	Up to Day 45
Secondary	change of SUVmean	Descriptively summarize the percent change from baseline to post-immunotherapy treatments.	Up to Day 45
Secondary	change of SUVmax	Descriptively summarize the percent change from baseline to post-immunotherapy treatments.	Up to Day 45