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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

Primary Purpose

Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Lung, Stage I Lung Cancer AJCC v8

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Indocyanine Green Solution
Therapeutic Bronchoscopy
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Lung Non-Small Cell Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device feasibility (bronchoscopy, CT, indocyanine green)

Arm Description

During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.

Outcomes

Primary Outcome Measures

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]).

Secondary Outcome Measures

Number of repositions required to deploy needle into lesion
Presence or absence of diagnostic tissue in sample
Evaluated using rapid cytology.
Indocyanine green visualized during robotic pulmonary resection
Number of cases that were begun as robotic or video-assisted that were converted to open in order to palpate nodule
Closest margin on resected nodule pathology
Proximity of needle to the lesion on first deployment
Evaluated retrospectively by research fellow using cone beam CT images.

Full Information

First Posted
June 26, 2021
Last Updated
May 30, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04987281
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Lung, Stage I Lung Cancer AJCC v8

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device feasibility (bronchoscopy, CT, indocyanine green)
Arm Type
Experimental
Arm Description
During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green Solution
Other Intervention Name(s)
IC-GREEN, ICG Solution
Intervention Description
Given via injection
Intervention Type
Device
Intervention Name(s)
Therapeutic Bronchoscopy
Intervention Description
Undergo bronchoscopy using Ion robotic bronchoscope
Primary Outcome Measure Information:
Title
Number of successful procedures out of 50
Description
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]).
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Number of repositions required to deploy needle into lesion
Time Frame
through study completion, an average of 1 year
Title
Presence or absence of diagnostic tissue in sample
Description
Evaluated using rapid cytology.
Time Frame
Up to 2 years
Title
Indocyanine green visualized during robotic pulmonary resection
Time Frame
through study completion, an average of 1 year
Title
Number of cases that were begun as robotic or video-assisted that were converted to open in order to palpate nodule
Time Frame
through study completion, an average of 1 year
Title
Closest margin on resected nodule pathology
Time Frame
Up to 2 years
Title
Proximity of needle to the lesion on first deployment
Description
Evaluated retrospectively by research fellow using cone beam CT images.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Rice, MD
Phone
(713) 563-9153
Email
drice@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Rice
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David C. Rice, MD
Phone
713-563-9153
Email
drice@mdanderson.org
First Name & Middle Initial & Last Name & Degree
David C. Rice, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

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