Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Lung, Stage I Lung Cancer AJCC v8
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREComputed Tomography
Undergo CT
Given via injection
DEVICETherapeutic Bronchoscopy
Undergo bronchoscopy using Ion robotic bronchoscope
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years * Medically operable * Undergoing pulmonary resection for either stage I non-small cell lung cancer (NSCLC) (undergoing segmentectomy) or metastatic disease to the lung * Lesions \< 2cm in longest diameter * Lesions are located at least 1cm from the pleura
Exclusion criteria
* Pregnant * Serum creatinine \> 2.0 * Central lesions * Iodide allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of successful procedures out of 50 | through study completion, an average of 1 year | 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 \[CT\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence or absence of diagnostic tissue in sample | Up to 2 years | Evaluated using rapid cytology. |
| Indocyanine green visualized during robotic pulmonary resection | through study completion, an average of 1 year | — |
| Number of repositions required to deploy needle into lesion | 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 | through study completion, an average of 1 year | Evaluated retrospectively by research fellow using cone beam CT images. |
| 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 | — |
Countries
United States
Outcome results
None listed