Lung Non-Small Cell CarcinomaPhase 2NCT04987281
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
A Phase 2 study testing Computed Tomography, Indocyanine Green Solution and Therapeutic Bronchoscopy in people with Lung Non-Small Cell Carcinoma and Metastatic Malignant Neoplasm in the Lung, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Lung, Stage I Lung Cancer AJCC v8
- What is being tested?
- Computed Tomography, Indocyanine Green Solution and Therapeutic Bronchoscopy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2022to 27 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant
- Serum creatinine > 2.0
- Central lesions
- Iodide allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resection of Pulmonary Lesions Aided by Robotic Bronchoscopy With Cone CT and INdocyanin Green (REPLACING) Study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Lung, Stage I Lung Cancer AJCC v8
- Being tested
- Computed Tomography, Indocyanine Green Solution, Therapeutic Bronchoscopy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo CT
Indocyanine Green SolutionDrug
Also called IC-GREEN, ICG Solution
Given via injection
Therapeutic BronchoscopyDevice
Undergo bronchoscopy using Ion robotic bronchoscope
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computed Tomography; Drug: Indocyanine Green Solution; Device: Therapeutic Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Number of repositions required to deploy needle into lesion
Measured: through study completion, an average of 1 year
Presence or absence of diagnostic tissue in sample
Evaluated using rapid cytology.
Measured: Up to 2 years
Indocyanine green visualized during robotic pulmonary resection
Measured: 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
Measured: through study completion, an average of 1 year
Closest margin on resected nodule pathology
Measured: Up to 2 years
Proximity of needle to the lesion on first deployment
Evaluated retrospectively by research fellow using cone beam CT images.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start26 Jan 2022
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Why it stopped: 0 ACTUAL Enrollment must have Overall Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David W Rice, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987281
- Sponsor's protocol ID
- 2021-0243
- Other IDs
- NCI-2021-05983, 2021-0243
- Status last verified
- Dec 2023
- First submitted
- 26 Jun 2021
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection of Pulmonary Lesions Aided by Robotic Bronchoscopy With Cone CT and INdocyanin Green (REPLACING) Study
- ClinicalTrials.gov ID
- NCT04987281
- Acronym / sponsor ID
- 2021-0243
- Conditions
- Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Lung, Stage I Lung Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 0 ACTUAL Enrollment must have Overall Recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device feasibility (bronchoscopy, CT, indocyanine green) | Experimental | Procedure: Computed Tomography, Drug: Indocyanine Green Solution, Device: Therapeutic BronchoscopyDuring standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant
- Serum creatinine > 2.0
- Central lesions
- Iodide allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo CT | Procedure or surgery | Device feasibility (bronchoscopy, CT, indocyanine green) |
| Indocyanine Green SolutionAlso: IC-GREEN, ICG SolutionGiven via injection | Drug | Device feasibility (bronchoscopy, CT, indocyanine green) |
| Therapeutic BronchoscopyUndergo bronchoscopy using Ion robotic bronchoscope | Device | Device feasibility (bronchoscopy, CT, indocyanine green) |
Primary outcome
Number of successful procedures out of 50
Time frame: 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]).
6 secondary outcomes
Number of repositions required to deploy needle into lesion
Time frame: through study completion, an average of 1 year
Presence or absence of diagnostic tissue in sample
Time frame: Up to 2 years
Indocyanine green visualized during robotic pulmonary resection
Time frame: 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
Time frame: through study completion, an average of 1 year
Closest margin on resected nodule pathology
Time frame: Up to 2 years
Proximity of needle to the lesion on first deployment
Time frame: through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Rice principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computed Tomography, Indocyanine Green Solution and Therapeutic Bronchoscopy in people with Lung Non-Small Cell Carcinoma and Metastatic Malignant Neoplasm in the Lung, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful procedures out of 50 (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.