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Robotic Bronchoscopy for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By David W Rice
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial uses a robotic bronchoscope with a mobile 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 lung metastases. The goal is to see the tumor more easily, which may allow for smaller incisions and less tissue damage.

Who is the study for?
This trial is for adults aged 18-80 with small lung tumors (less than 2cm) that are at least 1cm away from the pleura. It's aimed at those who can undergo surgery, specifically for stage I non-small cell lung cancer or lung metastases. People with central lesions, iodide allergies, pregnant individuals, or those with high serum creatinine levels (>2.0) cannot participate.Check my eligibility
What is being tested?
The study tests a robotic bronchoscopy combined with mobile CT scanning and indocyanine green dye injection to improve tumor visibility during surgery in patients with early-stage lung cancer or metastases to the lungs. The goal is to enable smaller incisions by clearly marking the tumor.See study design
What are the potential side effects?
Potential side effects may include reactions to indocyanine green such as allergic responses, issues related to bronchoscopy like discomfort or minor bleeding, and complications from CT imaging including exposure to radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of successful procedures out of 50
Secondary outcome measures
Closest margin on resected nodule pathology
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
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Device feasibility (bronchoscopy, CT, indocyanine green)Experimental Treatment3 Interventions
During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Indocyanine Green Solution
2018
N/A
~150

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,781 Total Patients Enrolled
David W RicePrincipal InvestigatorM.D. Anderson Cancer Center
David W PricePrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Therapeutic Bronchoscopy Clinical Trial Eligibility Overview. Trial Name: NCT04987281 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Device feasibility (bronchoscopy, CT, indocyanine green)
Non-Small Cell Lung Cancer Clinical Trial 2023: Therapeutic Bronchoscopy Highlights & Side Effects. Trial Name: NCT04987281 — Phase 2
Therapeutic Bronchoscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04987281 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are eligible to join this research project?

"Affirmative. The information accessible on clinicaltrials.gov indicates that this experiment, which was listed on January 26th 2022, is currently searching for participants. To complete the trial's objectives approximately 50 subjects must be enrolled from a single medical facility."

Answered by AI

What criteria must be satisfied to qualify for enrollment in this experiment?

"Up to 50 persons living with lung cancer, aged 18-80, are suitable for enrolment in this research. Prospective candidates should have lesions measuring less than 2 cm at the longest diameter and located no closer than 1cm from their pleura. Additionally, they must be prepared to undertake pulmonary resection either as a treatment of stage I non-small cell lung cancer or metastatic illness impacting the lungs."

Answered by AI

Are there any opportunities to participate in this clinical experiment presently?

"At present, the clinical trial outlined on clinicaltrials.gov is actively recruiting volunteers. This research project was initially made public on January 26th 2022 and last updated June 9th 2022."

Answered by AI

Does this research protocol restrict the age of participants to over 70 years old?

"This research project is recruiting participants aged 18 and over, but younger than 80."

Answered by AI

How does the use of Indocyanine Green Solution impact patient safety?

"Our team has rated Indocyanine Green Solution a 2 based on clinical data supporting its safety, but with no evidence of efficacy yet."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04987281.
~0 spots leftby Apr 2025
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