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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [89Zr]Zr-DFO-emapalumab | Experimental | Radiotracer [89Zr]Zr-DFO-emapalumab injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [89Zr]Zr-DFO-emapalumab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| peak Standard Uptake Value (SUVpeak) | Descriptively summarize at baseline and post-immunotherapy treatments. | Up to Day 45 |
| mean Standard Uptake Value (SUVmean) | Descriptively summarize at baseline and post-immunotherapy treatments. | Up to Day 45 |
| maximum Standard Uptake Value (SUVmax) | Descriptively summarize at baseline and post-immunotherapy treatments. | Up to Day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| change of SUVpeak | Descriptively summarize the percent change from baseline to post-immunotherapy treatments. | Up to Day 45 |
| change of SUVmean | Descriptively summarize the percent change from baseline to post-immunotherapy treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| change of SUVpeak by PET response | Descriptively summarize the percent change from baseline to post-immunotherapy by PET response | Up to Day 45 |
| change of SUVmean by PET response | Descriptively summarize the percent change from baseline to post-immunotherapy by PET response |
Inclusion
Exclusion
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nerissa T Viola, PhD | Contact | 3135768309 | violan@karmanos.org |
| Name | Affiliation | Role |
|---|---|---|
| Nerissa T Viola, PhD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
| Up to Day 45 |
| change of SUVmax | Descriptively summarize the percent change from baseline to post-immunotherapy treatments. | Up to Day 45 |
| Up to Day 45 |
| change of SUVmax by PET response | Descriptively summarize the percent change from baseline to post-immunotherapy by PET response | Up to Day 45 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |