Non Small Cell Lung Cancer
Conditions
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.
Interventions
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
Sponsors
Nerissa T. Viola
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum Standard Uptake Value (SUVmax) | Up to Day 45 | Descriptively summarize at baseline and post-immunotherapy treatments. |
| peak Standard Uptake Value (SUVpeak) | Up to Day 45 | Descriptively summarize at baseline and post-immunotherapy treatments. |
| mean Standard Uptake Value (SUVmean) | Up to Day 45 | Descriptively summarize at baseline and post-immunotherapy treatments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of SUVpeak | Up to Day 45 | Descriptively summarize the percent change from baseline to post-immunotherapy treatments. |
| change of SUVmean | Up to Day 45 | Descriptively summarize the percent change from baseline to post-immunotherapy treatments. |
| change of SUVmax | Up to Day 45 | Descriptively summarize the percent change from baseline to post-immunotherapy treatments. |
Countries
United States
Contacts
CONTACTNerissa T Viola, PhD
PRINCIPAL_INVESTIGATORNerissa T Viola, PhD
Barbara Ann Karmanos Cancer Institute
Outcome results
None listed