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

NCT ID: NCT07318402

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-23

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Operator Radiation Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Operator Radiation

During Image-Guided Robotic-Assisted Bronchoscopy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Or Kalchiem-Dekel, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Or Kalchiem-Dekel, MD

Role: CONTACT

212-639-5061

Catherine Oberg

Role: CONTACT

212-639-2773

Facility Contacts

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Or Kalchiem-Dekel, MD

Role: primary

212-639-5061

Related Links

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https://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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25-350

Identifier Type: -

Identifier Source: org_study_id

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