Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R44CA281581-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| Mayo Clinic |
Not provided
Not provided
Not provided
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.
The study includes four arms based on biopsy location and biopsy modality/tool:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ON-SITE Patients | Participants must fulfill all of the following criteria in order to be eligible for the study:
|
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral TBBx and CBx Co-primary Endpoints | Detection of lung cancer in peripheral TBBx and CBx biopsies by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation touch imprint cytology (ROSE-TIC) | From enrollment to the End of the Procedure. |
| Peripheral Lung Transbronchial Fine Needle Aspiration Endpoint | Detection of lung cancer in peripheral lung transbronchial needle aspiration by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation (ROSE). | From enrollment to the End of the Procedure. |
| Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration Endpoint | Determine area-under-the-curve (AUC) of the receiver-operating-characteristic (ROC) of NIO image analysis module for detection of cancer at a lymph-node location. | From enrollment to the End of the Procedure. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who are scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion.
Patients who meet criteria will be enrolled consecutively from 5 different Hospitals including MD Anderson Cancer Center, University of North Carolina Medical Center, Corewell Health, Montefiore Medical Center, Memorial Sloan Kettering Cancer Center, University of San Diego, Mayo Clinic
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | Recruiting | San Diego | California | 92037 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| University of California, San Diego | OTHER |
| Montefiore Medical Center-Moses-Weiler | UNKNOWN |
| Corewell Health | UNKNOWN |
Not provided
Not provided
Not provided
| Mayo Clinic Jacksonville | Not yet recruiting | Jacksonville | Florida | 32224 | United States |
|
| Corewell Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
|
| Memorial Sloan Kettering Cancer Center | Suspended | New York | New York | 10065 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
|
| UNC Medical Center | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
|
| MD Anderson Cancer Center | Active, not recruiting | Houston | Texas | 77030 | United States |