Clinical trial NCT04987281: Robotic Bronchoscopy With Cone CT and Indocyanine Green to Aid Removal of Lung Lesions in Patients With Stage I Non-small Cell Lung Cancer or Lung Metastases, REPLACING Study
Official title: Resection of Pulmonary Lesions Aided by Robotic Bronchoscopy With Cone CT and INdocyanin Green (REPLACING) Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lung Non-Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Lung
Stage I Lung Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of successful procedures out of 50
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of repositions required to deploy needle into lesion
timeFrame: through study completion, an average of 1 year
measure: Presence or absence of diagnostic tissue in sample
timeFrame: Up to 2 years
measure: Indocyanine green visualized during robotic pulmonary resection
timeFrame: through study completion, an average of 1 year
measure: Number of cases that were begun as robotic or video-assisted that were converted to open in order to palpate nodule
timeFrame: through study completion, an average of 1 year
measure: Closest margin on resected nodule pathology
timeFrame: Up to 2 years
measure: Proximity of needle to the lesion on first deployment
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David W Rice
role: PRINCIPAL_INVESTIGATOR
References: