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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00208724 | Other Identifier | JHM IRB |
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The study is terminated because the PI left the institution.
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| Name | Class |
|---|---|
| CellSight Technologies, Inc. | INDUSTRY |
| Stand Up To Cancer | OTHER |
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This is a prospective, single center, single-arm clinical trial in 20 patients with non-small cell lung cancer (NSCLC) undergoing PD-1/PD-L1-directed therapy. This research is being done to find out if the radioactive compound called [18F]F-AraG is a helpful imaging agent for detecting changes in cancer's anti-tumor immune response (or activation of T-cell) levels for non-small cell lung cancer (NSCLC) patients who will receive a cancer immunotherapy regimen (immunotherapy works by encouraging the body's own immune system to attack the cancer cells).
The purpose of this study is to find out how the radiotracer called [18F]F-AraG can help investigate changes in cancer's anti-tumor immune response (or activation of T-cell) levels during positron emission tomography (PET) scans. [18F]F-AraG has the potential to serve as a noninvasive imaging biomarker in the monitoring of T-cell mediated anti-tumor immune response following administration of an immunotherapeutic agent.
Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include about three clinic visits.
A baseline [18F]F-AraG PET-CT will be obtained 0-7 days before a NSCLC patient receives PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed 10-14 days after PD-1/PD-L1 immunotherapy is administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]F-AraG | Experimental | A one-time nominal injection dose of 5 millicurie (mCi) +/- will be administered at each PET/CT imaging time point. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]F-AraG Injection | Drug | Single dose of 5 mCi+/- [18F]F-AraG IV injection followed by the PET/CT scan. A baseline [18F]F-AraG PET/CT will be performed at about 0-7 days before patient receives the first dose of PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed at less than 14 days after the first dose of PD-1/PD-L1 immunotherapy is administered and before the second dose of PD-1/PD-L1 immunotherapy is given. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in uptake of [18F]F-AraG before and after one dose of anti-PD-L1 | Percent Change in standard uptake value (SUV) of [18F]F-AraG PET-CT imaging of primary tumor and of lymph nodes at baseline to after the first dose of neoadjuvant therapy. | Baseline and 10-14 days after first dose of neoadjuvant therapy |
| Percent pathologic response at the time of surgery | 100% minus the percentage of viable tumor remaining in the tumor bed. | At the time of surgery |
| Correlation between [18F]F-AraG uptake and percent pathologic response as assessed by the Spearman correlation coefficient | Spearman correlation coefficient will be calculated in assessing the correlation between [18F]F-AraG uptake and pathologic response. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Pomper, M.D., Ph.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | 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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|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |