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The purpose of this study to learn whether PET/CT (positron emission tomography/computed tomography) scans using an imaging agent (radiotracer) called zirconium Zr 89 crefmirlimab berdoxam is a safe and effective way to identify CD8+ T cells
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Metastatic non-small cell lung cancer (NSCLC) | Experimental | Participants will have a diagnosis of metastatic non-small cell lung cancer (NSCLC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zirconium Zr 89 crefmirlimab berdoxam | Drug | Zirconium Zr 89 crefmirlimab berdoxam, the investigational agent proposed in this imaging study, is an anti-CD8 minibody (crefmirlimab), conjugated with deferoxamine (Df, berdoxam) and radiolabeled with Zirconium-89. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between Zirconium Zr 89 crefmirlimab berdoxam PET uptake at pre- vs post-TIL infusion and pre- vs post-ACZ redosing. | Assess the distribution of the CD8+ cells during TIL therapy by measuring the largest difference in Zirconium Zr 89 crefmirlimab berdoxam PET uptake at pre- vs post-TIL infusion and pre- vs post-ACZ redosing. | Baseline to two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Schoenfeld, MD | Contact | 646-608-4042 | schoenfa@mskcc.org | |
| Alexander Shoushtari, MD | Contact | 646-888-4161 | shoushta@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Adam Schoenfeld, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Consent Only) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| PET/CT Scan | Diagnostic Test | Each patient will undergo up to four infusions of Zirconium Zr 89 crefmirlimab berdoxam followed by PET/CT 24 hours later (+/- 3 hours). |
|
| Memorial Sloan Kettering Monmouth (Consent Only) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Consent Only) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Consent only) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center (All protocol activities) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) | Recruiting | Uniondale | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
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