Operator Radiation ExposureNCT07318402
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
An observational study of Operator Radiation Exposure, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Operator Radiation Exposure
- How many people
- 350 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Dec 2025to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Operator performing standard of care image-guided robotic-assisted bronchoscopy for the sampling of a single pulmonary parenchymal lesion
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Catherine Oberg contact
United States4 sites, 4 recruiting
- Recruiting
Emory University (Data Collection Only)
Atlanta, Georgia, 30322
Abesh Niroula, MBBS, MD, 404-686-2505, abesh.niroula@emory.edu
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Or Kalchiem-Dekel, MD, 212-639-5061
- Recruiting
Orlando Health (Data Collection Only)
Orlando, Florida, 32806
Kim Styrvoky, MD, 407-648-5384
- Recruiting
Mayo Clinic (Data Collection Only)
Rochester, Minnesota, 55905
Bryan Husta, MD, 904-953-2000
About this study
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.
- Conditions
- Operator Radiation Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Operator Radiation | During Image-Guided Robotic-Assisted Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
total operator radiation exposure dose
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start23 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operator Radiation ExposureStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Or Kalchiem-Dekel, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318402
- Sponsor's protocol ID
- 25-350
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07318402
- Acronym / sponsor ID
- 25-350
- Conditions
- Operator Radiation Exposure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Jan 2026 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operator Radiation | – | –During Image-Guided Robotic-Assisted Bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Operator performing standard of care image-guided robotic-assisted bronchoscopy for the sampling of a single pulmonary parenchymal lesion
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Operator refusal to participate
- Image-guided RAB procedure performed on:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
total operator radiation exposure dose
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
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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.
Catherine Oberg contact
Or Kalchiem-Dekel, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Operator Radiation Exposure, run by Memorial Sloan Kettering Cancer Center at 4 sites 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Or Kalchiem-Dekel, MD (212-639-5061, kalchieo@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total operator radiation exposure dose (time frame: 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 2026.