RECRUITING

Confocal Laser Endomicroscopy VERification

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicenter Randomized Controlled Trial (CLEVER Trial)

Quick Facts

Study Start:2023-10-18
Study Completion:2025-10-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06079970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥18 years of age
  2. 2. Suspected malignant peripheral lung lesion with an indication for a bronchoscopic diagnostic work-up as determined by the attending physician or tumor board. Peripheral pulmonary lesions are defined as lesions located beyond the visible segmental bronchi, not detectable by regular flexible bronchoscopy
  3. 3. Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal
  4. 4. Solid part of the lesion must be ≧10 mm
  5. 5. Largest dimension of lesion size on CT ≦30 mm (long-axis)
  6. 6. Ability to understand and willingness to sign a written informed consent
  1. 1. Inability or non-willingness to provide informed consent
  2. 2. Endobronchial visible malignancy on bronchoscopic inspection
  3. 3. Target lesion within reach of the linear EBUS scope
  4. 4. Failure to comply with the study protocol
  5. 5. Known allergy or risk factors for an allergic reaction to fluorescein
  6. 6. Pregnancy or breastfeeding
  7. 7. Hemodynamic instability
  8. 8. Refractory hypoxemia
  9. 9. Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure
  10. 10. Unable to tolerate general anesthesia according to the anesthesiologist
  11. 11. Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g., doxorubicin)

Contacts and Locations

Study Contact

Saskia van Heumen, MSc
CONTACT
+31(0)20 566 2694
s.vanheumen@amsterdamumc.nl
Jouke Annema, Prof. dr.
CONTACT
j.t.annema@amsterdamumc.nl

Principal Investigator

Jouke Annema, Prof. dr.
PRINCIPAL_INVESTIGATOR
Amsterdam UMC

Study Locations (Sites)

Montefiore Medical Center
New York, New York, 10467
United States

Collaborators and Investigators

Sponsor: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

  • Jouke Annema, Prof. dr., PRINCIPAL_INVESTIGATOR, Amsterdam UMC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-18
Study Completion Date2025-10-18

Study Record Updates

Study Start Date2023-10-18
Study Completion Date2025-10-18

Terms related to this study

Keywords Provided by Researchers

  • Confocal Microscopy
  • Bronchoscopy
  • Confocal laser endomicroscopy
  • CLE
  • Fluoroscopy

Additional Relevant MeSH Terms

  • Lung Cancer
  • Lung Neoplasm Malignant
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm of Lung