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NCT06079970 · ClinicalTrials.gov registry record · NA
Confocal Laser Endomicroscopy VERification
A NA study of Lung Cancer and Carcinoma, Non-Small Cell Lung, sponsored by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC).
- Recruiting
- Registry status
- NA
- Development phase
- 208
- Enrollment target
- 7
- Study locations
NCT06079970: Recruiting NA study of Lung Cancer and Carcinoma, Non-Small Cell Lung, sponsored by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC).
NCT06079970 is a NA study of Lung Cancer and Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC). The registered enrollment target is 208 participants, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (78% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06079970, a NA study of Lung Cancer and Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC).
- RECRUITING
- Registry status
- NA
- Development phase
- 208 participants
- Enrollment target
- 7
- Study locations
Study Summary
The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy. The main question\[s\] it aims to answer are: To determine if the addition of nCLE-imaging to conventional diagnostic bronchoscopic peripheral lung lesion analysis results in an improved diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have received the diagnostic bronchoscopic procedure). Participants will undergo diagnostic bronchoscopy either with or without the addition of nCLE imaging before each TBNA. Based on the feedback of the CLE images on (in)correct placement of the needle, the needle might be repositioned before sampling. Comparison between the diagnostic yield of these groups will be done including subgroup analysis.
Primary Outcome
Diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis \[either malignant, specific benign or non-specific benign confirmed as benign in follow-up\], relative to the total number of patients that underwent the diagnostic bronchoscopic procedure). If patients with multiple lesions are included, the diagnostic yield will be computed per nodule.
Conditions Studied
Interventions
- DEVICE Neelde Based Confocal Laser Endomicroscopy
- PROCEDURE Conventional diagnostic bronchoscopy
Study Locations (7)
Other
- Vienna General Hospital - Vienna
- General University Hospital Prague - Prague
- Sotiria Hospital - Athens
- Morgagni Pierantoni Hospital - Forlì
- Amsterdam University Medical Centers - Amsterdam
- University Hospital basel - Basel
New York
- Montefiore Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2025-10-18 |
| Phase | NA |
Sponsor
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)1 total trials
What NCT06079970 shows while recruiting
NCT06079970 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 935-participant average among 409 other Lung Cancer trials with a reported enrollment target (78% lower).
The record links to 4 conditions, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Neelde Based Confocal Laser Endomicroscopy is the first listed.
NCT06079970 lists 7 locations in 2 states (Other, New York).
Frequently Asked Questions
What is clinical trial NCT06079970 about?
NCT06079970 is a clinical study titled "Confocal Laser Endomicroscopy VERification". The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for ma...
What is the current status of trial NCT06079970?
This trial is currently recruiting. It is a NA study. The enrollment target is 208 participants. The study started on 2023-10-18. Estimated completion is 2025-10-18.
What conditions does trial NCT06079970 study?
This clinical trial studies the following conditions: Lung Cancer, Carcinoma, Non-Small Cell Lung, Lung Neoplasm Malignant, Neoplasm of Lung.
What interventions are being tested in trial NCT06079970?
The interventions under investigation include: Neelde Based Confocal Laser Endomicroscopy (DEVICE), Conventional diagnostic bronchoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT06079970?
This trial is sponsored by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06079970 being conducted?
This trial has 7 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06079970's enrollment target sits among peer trials
208 128th of 409 higher than 282 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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