Combined Needle-based Confocal Laser Endomicroscopy Cone-Beam Computed Tomography Navigation Bronchoscopy: a Proof of Principle Study
New Bronchoscopy Technique for Lung Nodules
Plain English Summary
nCLE-Cone-beam CT Navigation Bronchoscopy is a Not Applicable clinical trial sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) studying Lung Neoplasm, Peripheral Lung Parenchyma Tumor, Lung Cancer. This study tests a new way to look at suspicious lung nodules using a special camera on a needle during a bronchoscopy. It's for patients 18 and older with a lung nodule that needs further investigation. Participation involves undergoing a standard bronchoscopy with the addition of a new imaging technique using a needle-based camera. Alternatives include traditional biopsies or imaging-based diagnoses without this specific combined technique. The trial aims to enroll 25 participants.
Official Summary
The goal of this proof of principle observational study is to investigate in patients with suspected peripheral pulmonary nodules. The main question it aims to answer is: • What is the concordance between CBCT navigation success (tool-in-lesion on CBCT spin) and nCLE tool-in-lesion confirmation (tool-in-lesion nCLE criteria observed). Participants scheduled to undergo a diagnostic conebeam navigation bronchoscopy will be included in the study. nCLE imaging at the tip of the TBNA needle will be added to the procedure for study purposes. Two needle punctures of the pulmonary nodule will be followed by nCLE imaging directly followed by a tool-in-lesion CBCT spin in order to compare nCLE results with CBCT results.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have a lung nodule that needs a closer look, as decided by doctors. The nodule must be at least 8mm in its solid part and no larger than 30mm. You cannot join if you have a visible tumor in your airways, if the nodule is easily reachable by standard scopes, or if you have allergies to fluorescein, are pregnant/breastfeeding, or have unstable health conditions. Patients on certain blood thinners or chemotherapy that interferes with imaging may also be excluded. This trial is studying Lung Neoplasm, Peripheral Lung Parenchyma Tumor, Lung Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see how well the new camera on the needle matches the results from a special CT scan in confirming the needle is in the right spot within the nodule. The specific primary outcome measures are: CBCT navigation success and nCLE tool-in-lesion confirmation (Intra-procedure). 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 explores a more precise method for diagnosing lung nodules, potentially improving accuracy and reducing the need for more invasive procedures. This research targets Lung Neoplasm, Peripheral Lung Parenchyma Tumor, Lung Cancer, where improved treatment options are needed.
Investor Insight
This study is a 'proof of principle' for a novel diagnostic tool in lung cancer, a large and competitive market, suggesting potential for improved early detection if successful.
Is This Trial Right for Me?
Ask your doctor if this new technique is appropriate for your specific lung nodule. You will undergo a bronchoscopy procedure, which involves a camera inserted into your lungs. The new technique adds a special camera at the tip of the biopsy needle to get a closer look at the nodule. The trial is being conducted at 1 site. 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: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 25 participants
Interventions
- DEVICE: needle-based confocal laser endomicroscopy — needle-based confocal laser endomicroscopy at the tip of the TBNA needle for two punctures, combined with confirmatory CBCT spin for tool-in-lesion confirmation
Primary Outcomes
- CBCT navigation success and nCLE tool-in-lesion confirmation (Intra-procedure)
Secondary Outcomes
- Technical feasibility (Intra-procedure)
- Safety (Up to 7 days post procedure)
- Diagnostic yield (up to 6 months post procedure)
- Diagnostic sensitivity for malignancy (up to 6 months post procedure)
- Sensitivity, specificity and accuracy of real-time nCLE imaging assessment (Intra-procedure)
Full Eligibility Criteria
Inclusion Criteria: * 18 years or older * Suspected pulmonary nodule with an indication for CBCT-NB (decided by multidisciplinary tumour board) * Nodule must be solid or partially solid * Solid part of the nodule must be at least 8 mm * Largest dimension of the nodule on CT equal or less than 30 mm * Ability to understand and willingness to sign a written informed consent Exclusion Criteria: * Inability or non-willingness to provide informed consent * Patients with an endobronchial visible lung tumor on bronchoscopic inspection * Patients in which the target lesion is within reach of the linear EBUS scope * Lung nodules that resolved at the time of index intraprocedural CBCT * Failure to comply with the study protocol * Patients with known allergy for fluorescein or risk factors for an allergic reaction * Pregnant or breastfeeding women * Patients with hemodynamic instability * Patients with refractory hypoxemia * Patients with a therapeutic anticoagulant that cannot be held for an appropriate in-terval before the procedure * Patients who are unable to tolerate general anesthesia according to the anesthesiologist * Patient undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g. doxorubicin)
Trial Locations
- Amsterdam UMC, Amsterdam, Netherlands
Frequently Asked Questions
What is clinical trial NCT06505642?
NCT06505642 is a Not Applicable INTERVENTIONAL study titled "nCLE-Cone-beam CT Navigation Bronchoscopy." It is currently active, not recruiting and is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial targets enrollment of 25 participants.
What conditions does NCT06505642 study?
This trial investigates treatments for Lung Neoplasm, Peripheral Lung Parenchyma Tumor, Lung Cancer. The primary condition under study is Lung Neoplasm.
What treatments are being tested in NCT06505642?
The interventions being studied include: needle-based confocal laser endomicroscopy (DEVICE). needle-based confocal laser endomicroscopy at the tip of the TBNA needle for two punctures, combined with confirmatory CBCT spin for tool-in-lesion confirmation
What does Not Applicable mean for NCT06505642?
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 NCT06505642?
This trial is currently "Active, Not Recruiting." It started on 2024-10-08. The estimated completion date is 2026-06.
Who is sponsoring NCT06505642?
NCT06505642 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06505642?
The trial aims to enroll 25 participants. The trial status is active, not recruiting.
How is NCT06505642 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06505642?
The primary outcome measures are: CBCT navigation success and nCLE tool-in-lesion confirmation (Intra-procedure). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06505642 being conducted?
This trial is being conducted at 1 site, including Amsterdam (Netherlands).
Where can I find official information about NCT06505642?
The official record for NCT06505642 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06505642. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06505642 testing in simple terms?
This study tests a new way to look at suspicious lung nodules using a special camera on a needle during a bronchoscopy. It's for patients 18 and older with a lung nodule that needs further investigation.
Why is this trial significant?
This trial explores a more precise method for diagnosing lung nodules, potentially improving accuracy and reducing the need for more invasive procedures.
What are the potential risks of participating in NCT06505642?
The main risks are similar to a standard bronchoscopy, including bleeding, infection, or air leak in the lung. There's a small risk of allergic reaction to the dye used with the camera, and potential discomfort or bruising at the needle insertion site. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06505642?
Ask your doctor if this new technique is appropriate for your specific lung nodule. You will undergo a bronchoscopy procedure, which involves a camera inserted into your lungs. The new technique adds a special camera at the tip of the biopsy needle to get a closer look at the nodule. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06505642 signal from an investment perspective?
This study is a 'proof of principle' for a novel diagnostic tool in lung cancer, a large and competitive market, suggesting potential for improved early detection if successful. 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 standard bronchoscopy with the addition of a new imaging technique using a needle-based camera. 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.
Related Conditions
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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.