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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-05983 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2021-0243 | Other Identifier | M D Anderson Cancer Center |
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0 ACTUAL Enrollment must have Overall Recruitment
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This phase II trial studies the use of Ion robotic bronchoscope with a mobile computed tomography (CT) scanner to biopsy tumors and inject a fluorescent dye called indocyanine green to mark the tumor during surgery in patients with stage I non-small cell lung cancer or cancer that has spread to the lung (lung metastases). Sometimes small tumors or those that are not on the surface of the lung can be challenging to remove without making larger incisions. Injecting the dye, may help doctors see the tumor more easily, which may allow for smaller incisions and by being able to see the tumor, doctors may be better able to decide where to make the incisions in order to get all of the tumor out.
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of using the Ion Endoluminal Platform (IEP; Intuitive, Sunnyvale, California [CA]) with the Cios Spin - a mobile cone-beam C - (Siemens Medical Solutions, Malvern, Pennsylvania [PA], United States [US]) in the operating room setting.
OUTLINE:
During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device feasibility (bronchoscopy, CT, indocyanine green) | Experimental | During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of successful procedures out of 50 | Success is defined as the ability of the provider to navigate to the lesion and deploy the needle into the lesion using the three allotted scans to aid in targeting to the lesion (As evaluated by surgeon using cone beam computed tomography [CT]). | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of repositions required to deploy needle into lesion | through study completion, an average of 1 year | |
| Presence or absence of diagnostic tissue in sample | Evaluated using rapid cytology. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W Rice | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 12, 2022 | Oct 21, 2024 |
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| Indocyanine Green Solution | Drug | Given via injection |
|
|
| Therapeutic Bronchoscopy | Device | Undergo bronchoscopy using Ion robotic bronchoscope |
|
| Up to 2 years |
| Indocyanine green visualized during robotic pulmonary resection | through study completion, an average of 1 year |
| Number of cases that were begun as robotic or video-assisted that were converted to open in order to palpate nodule | through study completion, an average of 1 year |
| Closest margin on resected nodule pathology | Up to 2 years |
| Proximity of needle to the lesion on first deployment | Evaluated retrospectively by research fellow using cone beam CT images. | through study completion, an average of 1 year |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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