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Trial Title:
First-in-human Study of Interferon-y PET Imaging to Assess Response to Immunotherapy
NCT ID:
NCT06439914
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[89Zr]Zr-DFO-emapalumab
Description:
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
Arm group label:
[89Zr]Zr-DFO-emapalumab
Other name:
Zirconium Zr 89-DFO-emapalumab
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nerissa T Viola, PhD
Phone:
3135768309
Email:
violan@karmanos.org
Contact backup:
Last name:
Nerissa T Viola, PhD
Contact backup:
Last name:
Anthony F Shields, MD, PhD
Contact backup:
Last name:
Hirva Mamdani, M.D.
Contact backup:
Last name:
Dipesh Uprety, M.D.
Contact backup:
Last name:
Ammar Sukari, M.D.
Contact backup:
Last name:
Tarik Hadid, MD, MPH, MS
Contact backup:
Last name:
Otto Muzik, PhD
Contact backup:
Last name:
Huailei Jiang, PhD
Start date:
January 2025
Completion date:
June 2027
Lead sponsor:
Agency:
Nerissa T. Viola
Agency class:
Other
Source:
Barbara Ann Karmanos Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06439914
