Lung BiopsyON-SITENCT07045103
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
An observational study of Lung Biopsy, run by Invenio Imaging Inc. at 7 sites in United States.
Trial summary
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Lung Biopsy
- How many people
- 900 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 Dec 2023to May 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion. Patients who meet criteria will be enrolled consecutively from 5 different Hospitals including MD Anderson Cancer Center, University of North Carolina Medical Center, Corewell Health, Montefiore Medical Center, Memorial Sloan Kettering Cancer Center, University of San Diego, Mayo Clinic
Who may be able to join
- The patient or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
- The patient is 22 years of age or older.
- The patient is scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion.
- The patient can tolerate the clinical procedure as indicated.
Who cannot join
- Patient is a prisoner.
- The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 5 recruiting
- Recruiting
UNC Medical Center
Chapel Hill, North Carolina, 27514
Jason Akulian, MD, 860-770-4835, akulian@email.unc.edu
Jason Akulian, MD
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
Gustavo Cumbo-Nachelli, MD, 616-821-8890, Gustavo.CumboNacheli@corewellhealth.org
Gustavo Cumbo-Nachelli, MD
- Active, not recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Not yet recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Bryan Husta, MD, (904) 953-2861, Husta.Bryan@mayo.edu
Bryan Husta, MD
- Suspended
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
UC San Diego
San Diego, California, 92037
George Z Cheng, MD, 619-543-5840, gcheng@ucsd.edu
George Z Cheng, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Daniel Da Costa, MD, 718-920-6441, daniel.dacosta@nyulangone.org
Daniel Da Costa, MD
About this study
Official title: A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.
The study includes four arms based on biopsy location and biopsy modality/tool:
- Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)
- Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)
- Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)
- Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)
- Conditions
- Lung Biopsy
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 |
|---|---|---|
| ON-SITE Patients | Participants must fulfill all of the following criteria in order to be eligible for the study: 1. The patient or legal guardian is willing and able to understand, sign and date the Ethics committee-approved study specific Informed Consent Form. 2. The patient is 22 years of age or older. 3. The patient is scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral-TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion. 4. The patient can tolerate the clinical procedure as indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral TBBx and CBx Co-primary Endpoints
Detection of lung cancer in peripheral TBBx and CBx biopsies by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation touch imprint cytology (ROSE-TIC)
Measured: From enrollment to the End of the Procedure.
Peripheral Lung Transbronchial Fine Needle Aspiration Endpoint
Detection of lung cancer in peripheral lung transbronchial needle aspiration by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation (ROSE).
Measured: From enrollment to the End of the Procedure.
Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration Endpoint
Determine area-under-the-curve (AUC) of the receiver-operating-characteristic (ROC) of NIO image analysis module for detection of cancer at a lymph-node location.
Measured: From enrollment to the End of the Procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start21 Dec 2023
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung BiopsyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Invenio Imaging Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center, University of North Carolina, Chapel Hill, M.D. Anderson Cancer Center, Mayo Clinic, University of California, San Diego, Montefiore Medical Center-Moses-Weiler, Corewell Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045103
- Sponsor's protocol ID
- INV-01-2022
- Other IDs
- 1R44CA281581-01
- Acronym
- ON-SITE
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection
- ClinicalTrials.gov ID
- NCT07045103
- Acronym / sponsor ID
- ON-SITE / INV-01-2022
- Conditions
- Lung Biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Invenio Imaging Inc.Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center, University of North Carolina, Chapel Hill, M.D. Anderson Cancer Center, Mayo Clinic, University of California, San Diego, Montefiore Medical Center-Moses-Weiler, Corewell Health
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.
The study includes four arms based on biopsy location and biopsy modality/tool:
- Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)
- Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)
- Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)
- Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ON-SITE Patients | – | –Participants must fulfill all of the following criteria in order to be eligible for the study: 1. The patient or legal guardian is willing and able to understand, sign and date the Ethics committee-approved study specific Informed Consent Form. 2. The patient is 22 years of age or older. 3. The patient is scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral-TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion. 4. The patient can tolerate the clinical procedure as indicated. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion. Patients who meet criteria will be enrolled consecutively from 5 different Hospitals including MD Anderson Cancer Center, University of North Carolina Medical Center, Corewell Health, Montefiore Medical Center, Memorial Sloan Kettering Cancer Center, University of San Diego, Mayo Clinic
Key inclusion criteria (4 listed)
- The patient or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
- The patient is 22 years of age or older.
- The patient is scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion.
- The patient can tolerate the clinical procedure as indicated.
Key exclusion criteria (2 listed)
- Patient is a prisoner.
- The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures
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
Peripheral TBBx and CBx Co-primary Endpoints
Time frame: From enrollment to the End of the Procedure.
Detection of lung cancer in peripheral TBBx and CBx biopsies by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation touch imprint cytology (ROSE-TIC)
Peripheral Lung Transbronchial Fine Needle Aspiration Endpoint
Time frame: From enrollment to the End of the Procedure.
Detection of lung cancer in peripheral lung transbronchial needle aspiration by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation (ROSE).
Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration Endpoint
Time frame: From enrollment to the End of the Procedure.
Determine area-under-the-curve (AUC) of the receiver-operating-characteristic (ROC) of NIO image analysis module for detection of cancer at a lymph-node location.
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 1 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Biopsy, run by Invenio Imaging Inc. at 7 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 4 inclusion and 2 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral TBBx and CBx Co-primary Endpoints (time frame: From enrollment to the End of the Procedure.). The study lists 3 primary outcomes in all. 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 1 Jul 2025.