Measuring operator radiation exposure during image-guided robotic bronchoscopy
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
This study will measure how much radiation bronchoscopists are exposed to while performing standard image-guided robotic-assisted bronchoscopy on adult patients with a single lung lesion.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07318402 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm observational study designed to record bronchoscopist radiation dose during standard-of-care image-guided robotic-assisted bronchoscopy (RAB) for sampling of a single pulmonary parenchymal lesion. Each participating site enrolls one operator who wears radiation dosimeters during routine RAB procedures, and no changes to patient care are required. Patients under 18, pregnant patients, cases sampling more than one lesion, localization-only procedures, and therapeutic procedures are excluded. Collected data will describe operator exposure patterns across procedures and settings to inform safety practices.
Who should consider this trial
Good fit: Adult patients (age ≥18) scheduled to undergo standard-of-care image-guided robotic-assisted bronchoscopy to sample a single pulmonary parenchymal lesion at a participating site are ideal candidates.
Not a fit: Patients who are under 18, pregnant, having multiple lesions sampled, undergoing localization-only procedures, or having therapeutic interventions are excluded and are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could inform safer radiation protection practices for bronchoscopists and indirectly improve procedural safety for patients.
How similar studies have performed: Radiation exposure to operators has been documented in conventional bronchoscopy and other image-guided procedures, but measuring dose specifically during image-guided robotic-assisted bronchoscopy is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Operator performing image-guided RAB on adult patients (age ≥18 years old) * A single participating operator per study site * Image-guided RAB procedure is planned for standard of care diagnostic sampling of a single parenchymal lung lesion at participating sites Exclusion Criteria: * Operator refusal to participate * Image-guided RAB procedure performed on: * Patients age \<18 years old * Pregnant women * Patients undergoing standard of care robotic assisted bronchoscopy with plan to sample \>1 pulmonary parenchymal lesion * Patients undergoing standard of care robotic assisted bronchoscopy for lesion localization (injection of dye/marker or fiducial marker deployment) * Patients undergoing standard of care robotic assisted bronchoscopy for a therapeutic intervention
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Or Kalchiem-Dekel, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Or Kalchiem-Dekel, MD
- Email: kalchieo@mskcc.org
- Phone: 212-639-5061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.