Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07318402

Enrollment

350

Registered

2026-01-06

Start date

2025-12-23

Completion date

2028-12-01

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Operator Radiation Exposure

Brief summary

This is a multicenter, single-arm, prospective, observational study designed to evaluate bronchoscopist radiation exposure during standard-of-care image-guided robotic-assisted bronchoscopy (RAB) for sampling of a single pulmonary parenchymal lesion.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
total operator radiation exposure dose	1 year	as captured by a radiation dosimetry badge over 50 consecutive procedures. All study procedures in which image-guided RAB was performed for the sampling of a single parenchymal lung lesion will be evaluable for the primary endpoint.

Countries

United States

Contacts

CONTACTOr Kalchiem-Dekel, MD

kalchieo@mskcc.org212-639-5061

CONTACTCatherine Oberg

212-639-2773

PRINCIPAL_INVESTIGATOROr Kalchiem-Dekel, MD

Memorial Sloan Kettering Cancer Center

Outcome results