Trial Outcomes & Findings for Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules (NCT NCT05556525)

Last Updated: 2025-09-17

Results Overview

Calculated as the proportion of patients for which first-pass transbronchial needle aspiration during bronchoscopic procedure yielded a definitive diagnosis out of the total number of patients that have received a diagnostic procedure.

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

Baseline

Results posted on

2025-09-17

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (EBUS TBNA) Patients undergo robotic EBUS TBNA on study. Ultrasound-Guided Transbronchial Needle Aspiration: Undergo EBUS TBNA	Arm II (EBUS TBNA, nCLE, Fluorescein) Patients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study. Fluorescein: Given IV Image-Guided Needle Confocal Laser Endomicroscopy: Undergo nCLE Ultrasound-Guided Transbronchial Needle Aspiration: Undergo EBUS TBNA
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Needle-Based Confocal Laser Endomicroscopy for Diagnosis of Lung Cancer in Patients With Peripheral Pulmonary Nodules

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (EBUS TBNA) n=2 Participants Patients undergo robotic EBUS TBNA on study. Ultrasound-Guided Transbronchial Needle Aspiration: Undergo EBUS TBNA	Arm II (EBUS TBNA, nCLE, Fluorescein) n=1 Participants Patients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study. Fluorescein: Given IV Image-Guided Needle Confocal Laser Endomicroscopy: Undergo nCLE Ultrasound-Guided Transbronchial Needle Aspiration: Undergo EBUS TBNA	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	2 participants n=99 Participants	1 participants n=107 Participants	3 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline

Population: The first-pass diagnostic yield could not be determined. Samples obtained at first pass were not separated from remaining samples collected during the procedure, and samples were sent to pathology together, not as per-pass yields. Per-patient (overall) diagnostic yield is reported in outcome 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to 12 months following procedure

Population: For all patients, diagnostic yield was confirmed true during follow-up. The patient who tested negative for malignancy had scar tissue. For the patients who tested positive, one was stable (no change in nodule) during follow-up. The other was diagnosed with adenocarcinoma with enteric origin and metastasis was confirmed; noticed of death was received 10/25/2024 (post follow-up).

Calculated as the proportion of patients in whom the bronchoscopic procedure yielded a definitive diagnosis out of the total number of patients that have received a diagnostic procedure. Per patient diagnostic yield of each bronchoscopic procedure will be calculated, and the accuracy of each technique using the final/definitive diagnosis as the reference. The diagnostic yield and accuracy for each method will be compared.

Outcome measures

Outcome measures
Measure	Arm I (EBUS TBNA) n=2 Participants Patients undergo robotic EBUS TBNA on study. Ultrasound-Guided Transbronchial Needle Aspiration: Undergo EBUS TBNA	Arm II (EBUS TBNA, nCLE, Fluorescein) n=1 Participants Patients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study. Fluorescein: Given IV Image-Guided Needle Confocal Laser Endomicroscopy: Undergo nCLE Ultrasound-Guided Transbronchial Needle Aspiration: Undergo EBUS TBNA
Per-patient Diagnostic Yield Negative for carcinoid or malignancy	0 Participants	1 Participants
Per-patient Diagnostic Yield Positive for carcinoid or malignancy	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months following procedure

Assessed by determining the proportion of patients with a correct change in definitive diagnosis and the associated change in management plan with nCLE.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (EBUS TBNA)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Arm II (EBUS TBNA, nCLE, Fluorescein)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I (EBUS TBNA) n=2 participants at risk Patients undergo robotic EBUS TBNA on study. Ultrasound-Guided Transbronchial Needle Aspiration: Undergo EBUS TBNA	Arm II (EBUS TBNA, nCLE, Fluorescein) n=1 participants at risk Patients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study. Fluorescein: Given IV Image-Guided Needle Confocal Laser Endomicroscopy: Undergo nCLE Ultrasound-Guided Transbronchial Needle Aspiration: Undergo EBUS TBNA
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • Number of events 1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).	0.00% 0/1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).
General disorders Non-cardiac Chest Pain	50.0% 1/2 • Number of events 1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).	0.00% 0/1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).
Nervous system disorders Paresthesia	50.0% 1/2 • Number of events 1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).	0.00% 0/1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 1/2 • Number of events 1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).	0.00% 0/1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).
Nervous system disorders Peripheral Motor Neuropathy	50.0% 1/2 • Number of events 1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).	0.00% 0/1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).
General disorders Edema Limbs	50.0% 1/2 • Number of events 1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).	0.00% 0/1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).
Renal and urinary disorders Nocturia	50.0% 1/2 • Number of events 1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).	0.00% 0/1 • Patients were followed for 12 months (baseline assessment at enrollment to 12-month follow-up assessment/record review). Report of deceased patient was received at 17 months, 1 week (post follow-up).

Additional Information

Dr. Sebastian Fernandez-Bussy

Mayo Clinic

Phone: 904-953-6320

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place