Needle-based Confocal Laser Endomicroscopy Guided For Lung Cancer Diagnosis: A Randomized Controlled Trial
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-008276
- Jacksonville, Florida: 21-008276
NCT ID: NCT05556525
Sponsor Protocol Number: MKT_2021_lung_01
About this study
The purpose of this study is to compare per pass diagnostic yield of different numbers of sequential needle passes (ROSE) and the procedure duration needed to obtain a contributive TBNA sample with ROBOTIC-guided TBNA to that of ROBOTIC-guided nCLE in PPNs.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 18 years of age.
- Suspected or tissue proven lung tumor and/or malignant peripheral/hilar lymph nodes.
- Nodule size in CT between 8mm and 30 mm (largest dimension).
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document.
Exclusion Criteria:
- Inability or non-willingness to provide informed consent.
- Inability to comply with the study protocol.
- Patients with known allergy for fluorescein or risk factors for an allergic reaction.
- Use of beta-blocker within 24 hours before start of the bronchoscopic procedure.
- Possible pregnant or lactating women.
- Known allergy to fluorescein.
- Patients with hemodynamic instability.
- Patients with refractory hypoxemia.
- Patients with therapeutic anticoagulant that cannot be held for an appropriate interval prior to the procedure.
- Patients who are unable to tolerate general anesthesia according to the anesthesiologist.
- Patient undergoing chemotherapy.
- Pregnant or breast feeding.
Intra-operative Exclusion/Stopping Criteria:
- The lesions are unable to be localized/confirmed by bronchoscopy.
- The procedure will be terminated if the patient develops a significant procedural complication as determined by the treating physician.
- The procedure will be terminated if the patient develops hemodynamic instability as determined by the treating physician.
Eligibility last updated 8/16/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Janani Reisenauer, M.D. |
Contact us for the latest status |
Contact information:
Thoracic Surgery Research Unit
(877) 526-9172
|
Jacksonville, Fla.
Mayo Clinic principal investigator Sebastian Fernandez-Bussy, M.D. |
Open for enrollment |
Contact information:
Clinical Studies Unit
(904) 953-2255
|
More information
Publications
Publications are currently not available