Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicenter Randomized Controlled Trial (CLEVER Trial)
New trial tests advanced imaging to improve lung nodule diagnosis
Plain English Summary
Confocal Laser Endomicroscopy VERification is a Not Applicable clinical trial sponsored by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) studying Lung Cancer, Lung Neoplasm Malignant, Carcinoma, Non-Small-Cell Lung, Neoplasm of Lung. This trial tests a new imaging technique called needle-based confocal laser endomicroscopy (nCLE) during bronchoscopy to see if it helps doctors get a more accurate diagnosis for lung nodules. It is for patients who have a lung nodule that is suspected to be cancerous and requires a diagnostic procedure called bronchoscopy. Participation involves undergoing a bronchoscopy procedure, which may or may not include the new nCLE imaging technique. Doctors will use the imaging to guide needle biopsies. The alternative is a standard bronchoscopy without the nCLE imaging, which is the current common practice for diagnosing lung nodules. The trial aims to enroll 208 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a suspected cancerous lung nodule that is not easily visible during a standard bronchoscopy. Patients must have a nodule that is between 10mm and 30mm in size and can be reached by a special scope. Individuals who are pregnant, breastfeeding, have unstable health, or are undergoing chemotherapy may not be eligible. People with known allergies to fluorescein dye or those who cannot undergo general anesthesia will also be excluded. This trial is studying Lung Cancer, Lung Neoplasm Malignant, Carcinoma, Non-Small-Cell Lung, Neoplasm of Lung, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how often the bronchoscopy procedure, with or without the new imaging, leads to a clear diagnosis of the lung nodule, meaning patients will know sooner if they have cancer The specific primary outcome measures are: Diagnostic yield (intermediate definition) (After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to improve the accuracy of diagnosing lung nodules, potentially leading to earlier and more effective treatment for lung cancer by using advanced imaging during a standard procedure. This research targets Lung Cancer, Lung Neoplasm Malignant, Carcinoma, Non-Small-Cell Lung, Neoplasm of Lung, where improved treatment options are needed.
Investor Insight
This trial addresses a critical need for improved diagnostic accuracy in lung cancer, a leading cause of cancer death, potentially offering a competitive edge to technologies that enhance early detect
Is This Trial Right for Me?
Ask your doctor if the new imaging technique (nCLE) is suitable for your specific lung nodule and if it could improve your diagnosis. Be prepared to discuss your full medical history, including any allergies, current medications, and any possibility of pregnancy. The day-to-day involvement is minimal, primarily consisting of attending scheduled appointments for the bronchoscopy procedure and any necessary follow-up. This trial is currently recruiting participants. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 208 participants
Interventions
- DEVICE: Neelde Based Confocal Laser Endomicroscopy — Confocal microscopy through the TBNA needle before tissue sampling using the Cellvizio system and AQ flex probe (Mauna Kea Technologies)
- PROCEDURE: Conventional diagnostic bronchoscopy — Conventional diagnostic bronchoscopy with r-EBUS and optionally fluoroscopy AND/OR EMN AND/OR VB AND/OR ultrathin scope
Primary Outcomes
- Diagnostic yield (intermediate definition) (After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years))
Secondary Outcomes
- Diagnostic sensitivity (After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years))
- Diagnostic yield (strict definition) (After all patients have been included (expected total time frame 2 years))
- Procedure duration (During procedure (bronchoscopy))
- Proportion needle repositionings and fine-tuning (During procedure (bronchoscopy))
- Fluoroscopy time/dose (During procedure (bronchoscopy))
Full Eligibility Criteria
Inclusion Criteria: 1. ≥18 years of age 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. Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal 4. Solid part of the lesion must be ≧10 mm 5. Largest dimension of lesion size on CT ≦30 mm (long-axis) 6. Ability to understand and willingness to sign a written informed consent Exclusion Criteria: 1. Inability or non-willingness to provide informed consent 2. Endobronchial visible malignancy on bronchoscopic inspection 3. Target lesion within reach of the linear EBUS scope 4. Failure to comply with the study protocol 5. Known allergy or risk factors for an allergic reaction to fluorescein 6. Pregnancy or breastfeeding 7. Hemodynamic instability 8. Refractory hypoxemia 9. Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure 10. Unable to tolerate general anesthesia according to the anesthesiologist 11. Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g., doxorubicin)
Trial Locations
- Montefiore Medical Center, New York, New York, United States
- Vienna General Hospital, Vienna, Austria
- General University Hospital Prague, Prague, Czechia
- Sotiria Hospital, Athens, Greece
- Amsterdam University Medical Centers, Amsterdam, Netherlands
Frequently Asked Questions
What is clinical trial NCT06079970?
NCT06079970 is a Not Applicable INTERVENTIONAL study titled "Confocal Laser Endomicroscopy VERification." It is currently recruiting and is sponsored by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC). The trial targets enrollment of 208 participants.
What conditions does NCT06079970 study?
This trial investigates treatments for Lung Cancer, Lung Neoplasm Malignant, Carcinoma, Non-Small-Cell Lung, Neoplasm of Lung. The primary condition under study is Lung Cancer.
What treatments are being tested in NCT06079970?
The interventions being studied include: Neelde Based Confocal Laser Endomicroscopy (DEVICE), Conventional diagnostic bronchoscopy (PROCEDURE). Confocal microscopy through the TBNA needle before tissue sampling using the Cellvizio system and AQ flex probe (Mauna Kea Technologies)
What does Not Applicable mean for NCT06079970?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06079970?
This trial is currently "Recruiting." It started on 2023-10-18. The estimated completion date is 2026-12-31.
Who is sponsoring NCT06079970?
NCT06079970 is sponsored by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC). The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06079970?
The trial aims to enroll 208 participants. The trial is currently recruiting and accepting new participants.
How is NCT06079970 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06079970?
The primary outcome measures are: Diagnostic yield (intermediate definition) (After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06079970 being conducted?
This trial is being conducted at 5 sites, including New York, New York; Vienna; Prague; Athens and 1 more sites (United States, Austria, Czechia).
Where can I find official information about NCT06079970?
The official record for NCT06079970 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06079970. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06079970 testing in simple terms?
This trial tests a new imaging technique called needle-based confocal laser endomicroscopy (nCLE) during bronchoscopy to see if it helps doctors get a more accurate diagnosis for lung nodules. It is for patients who have a lung nodule that is suspected to be cancerous and requires a diagnostic procedure called bronchoscopy.
Why is this trial significant?
This trial aims to improve the accuracy of diagnosing lung nodules, potentially leading to earlier and more effective treatment for lung cancer by using advanced imaging during a standard procedure.
What are the potential risks of participating in NCT06079970?
The main risks are those associated with any bronchoscopy, such as bleeding, infection, or a collapsed lung. There is a small risk of allergic reaction to the fluorescein dye used with the nCLE imaging. The new imaging technique might not always provide a clearer picture, and repositioning the needle could slightly increase procedure time. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06079970?
Ask your doctor if the new imaging technique (nCLE) is suitable for your specific lung nodule and if it could improve your diagnosis. Be prepared to discuss your full medical history, including any allergies, current medications, and any possibility of pregnancy. The day-to-day involvement is minimal, primarily consisting of attending scheduled appointments for the bronchoscopy procedure and any necessary follow-up. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06079970 signal from an investment perspective?
This trial addresses a critical need for improved diagnostic accuracy in lung cancer, a leading cause of cancer death, potentially offering a competitive edge to technologies that enhance early detect This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves undergoing a bronchoscopy procedure, which may or may not include the new nCLE imaging technique. Doctors will use the imaging to guide needle biopsies. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.