Lung Percutaneous BiopsyNCT02224885
Needle-based Confocal Laser Endomicroscopy in Fluoroscopy-guided Procedures
A study testing CT-guided percutaneous biopsy or ablation in people with Lung Percutaneous Biopsy and Liver Percutaneous Biopsy, run by Mauna Kea Technologies at 1 site in France.
Trial summary
This study is a prospective study in order to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: lung and liver. This innovative study will involve the use of probe-based confocal laser endomicroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Percutaneous Biopsy, Liver Percutaneous Biopsy
- What is being tested?
- CT-guided percutaneous biopsy or ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to have an interventional radiology procedure for needle-biopsy or radiofrequency ablation purposes in lung or in liver, 18 years or older.
- Only subjects who have provided written informed consent for the study can be included in the study.
Who cannot join
- Known allergy to fluorescein
- Previous life-threatening allergic reactions and known hypersensitivity to contrast media
- Pregnancy or breast-feeding
- History of cardio-pulmonary disease (including bronchial asthma)
- Restricted renal function
- Elderly with diabetes mellitus
- Patients under a beta-blockers treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Needle-based Confocal Laser Endomicroscopy in Fluoroscopy-guided Procedures for Lung Applications (Biopsies and Ablation) and Liver Procedures in Interventional Radiology: a Feasibility Study
This study is a prospective study in order to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: lung and liver.
This innovative study will involve the use of probe-based confocal laser endomicroscopy. The proposed study is a feasibility study.
Read the detailed description
Interventional radiology is a medical sub-specialty of radiology which utilizes minimally-invasive image-guided procedures to diagnose and treat diseases in nearly every organ. The concept behind interventional radiology is to diagnose and treat patients using less invasive techniques currently available in order to minimize risk to the patient and improve health outcomes.
For many years, surgery was the only treatment available for many conditions. Today, interventional radiology treatments are frst-line care for a wide variety of conditions. Patients should be offered the least invasive option frst. It is important to get a second opinion and know all of your treatment options before consenting to any procedure or surgery. Interventional radiologists are specialists in minimally invasive treatments, have a unique breadth of training and provide consults to every type of specialist.
Surgical removal of liver tumors offers the best chance for a cure. Unfortunately, liver tumors are often inoperable because the tumor may be too large, or has grown into major blood vessels or other vital structures. Sometimes, many small tumors are spread throughout the liver, making surgery too risky or impractical. Surgical removal is not possible for more than two-thirds of primary liver cancer patients and 90 percent of patients with secondary liver cancer.
The objectives of this study are to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: lung and liver.
The goal is to determine whether:
- Cellvizio insertion during the interventional procedure leads to change in known adverse events / serious adverse events rate during and one month after the procedure
- It is technically feasible to obtain images from Cellvizio during an interventional radiology procedure
- Cellvizio is a helpful assistance to increase the efficacy of biopsy which require to evaluate its accuracy eg. the predictive value of Cellvizio compared to pathology results.
Secondary goals are to assess:
- Benefit of spatial accuracy for the yield of the biopsy procedure and potential subsequent intervention, e.g. radiofrequency ablation.
- Regarding lung biopsies and lung ablation, potential increase of a database to refine image interpretation criteria with pathologists.
- In liver application, the goal is to build a database of images and define image interpretation criteria with pathologists to start image interpretation work.
- The predictive value of biopsies with Cellvizio assistance for lung or liver tumor biopsies.
For both applications, technical feedback from the physicians is expected on how they think the combined use of the devices could change the care path. E.g. a certain step in the workflow might become obsolete or the workflow could lead to fewer patient visits.
For the safety of this protocol, the use of endomicroscopy will not change in any way the patient management and standard procedure, including the diagnosis nor treatment decisions. All the adverse events / serious adverse events will be noted during the procedure and one week after the procedure.
- Being tested
- CT-guided percutaneous biopsy or ablation
- Keywords
- Interventional radiology, Lung, Liver, Confocal endomicroscopy, Optical biopsy, Scanner, Fluoroscopy, CT, Computed Tomography, Radiofrequency Ablation, Fluorescein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided percutaneous biopsy or ablationDevice
Standard interventional radiology procedure for a biopsy or ablation in the liver or in the lung
| Study group | Role | What they receive |
|---|---|---|
| addition of nCLE to help target biopsy | Other | The patient, scheduled for a liver or lung CT-guided percutaneous biopsy or ablation will undergo a probe-based confocal laser endomicroscopy procedure after the imaging procedure. The objectives of this study are to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure and determine whether it is technically feasible to obtain images from Cellvizio during an interventional radiology procedure. Receives: Device: CT-guided percutaneous biopsy or ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure adverse events frequency in the use of mini probes on the tumor
Assessment of the safety of inserting Cellvizio confocal miniprobe in the tumor (nor increase in bleeding or tumor cell dissemination) through the frequency, type and severity of adverse events
Measured: Up to 1 week
Secondary outcomes (4)
Creation of image bank
A frst creation of an atlas of endomicroscopic images obtained in interventional radiology in the liver - for the lung, the atlas established for peripheral lung nodules in bronchoscopy applications will serve as a reference and will be tested prospectively.
Measured: Up to 6 months
Yield of nCLE (needle-based confocal laser endomicroscopy)-targeted Fluoroscopy-guided biopsies
Yield of nCLE (needle-based confocal laser endomicroscopy)-targeted Fluoroscopy-guided biopsies to assess improvements compared to standard of care from guidance function of the device combination.
Measured: Up to 5 months
Evaluation of potential benefits of the device combination
Potential clinical, operational and financial benefits of the combination of Mauna Kea Technologies' endomicroscopic solution and Siemens' C-arm solution derived from the improved decision making for treatment of lung and liver lesions during the procedure (a clinical benefit could be fewer negative biopsies; an operational benefit could be one step fewer in the care path and a financial benefit could be a quicker diagnosis/treatment time, thus being able to release the patient earlier).
Measured: Up to 5 months
Assessment of accuracy and predictive value of interpretation criteria
Evaluation of the predictive value of Cellvizio as an increasing tool of biopsy performance.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Percutaneous BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mauna Kea Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivier PELLERIN, Principal investigator, HEGP, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224885
- Sponsor's protocol ID
- MKT-IR-HEGP-2014
- Status last verified
- Apr 2016
- First submitted
- 28 Jul 2014
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needle-based Confocal Laser Endomicroscopy in Fluoroscopy-guided Procedures for Lung Applications (Biopsies and Ablation) and Liver Procedures in Interventional Radiology: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02224885
- Acronym / sponsor ID
- MKT-IR-HEGP-2014
- Keywords
- Interventional radiology, Lung, Liver, Confocal endomicroscopy, Optical biopsy, Scanner, Fluoroscopy, CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mauna Kea TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective study in order to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: lung and liver.
This innovative study will involve the use of probe-based confocal laser endomicroscopy. The proposed study is a feasibility study.
Detailed description
Interventional radiology is a medical sub-specialty of radiology which utilizes minimally-invasive image-guided procedures to diagnose and treat diseases in nearly every organ. The concept behind interventional radiology is to diagnose and treat patients using less invasive techniques currently available in order to minimize risk to the patient and improve health outcomes.
For many years, surgery was the only treatment available for many conditions. Today, interventional radiology treatments are frst-line care for a wide variety of conditions. Patients should be offered the least invasive option frst. It is important to get a second opinion and know all of your treatment options before consenting to any procedure or surgery. Interventional radiologists are specialists in minimally invasive treatments, have a unique breadth of training and provide consults to every type of specialist.
Surgical removal of liver tumors offers the best chance for a cure. Unfortunately, liver tumors are often inoperable because the tumor may be too large, or has grown into major blood vessels or other vital structures. Sometimes, many small tumors are spread throughout the liver, making surgery too risky or impractical. Surgical removal is not possible for more than two-thirds of primary liver cancer patients and 90 percent of patients with secondary liver cancer.
The objectives of this study are to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: lung and liver.
The goal is to determine whether:
- Cellvizio insertion during the interventional procedure leads to change in known adverse events / serious adverse events rate during and one month after the procedure
- It is technically feasible to obtain images from Cellvizio during an interventional radiology procedure
- Cellvizio is a helpful assistance to increase the efficacy of biopsy which require to evaluate its accuracy eg. the predictive value of Cellvizio compared to pathology results.
Secondary goals are to assess:
- Benefit of spatial accuracy for the yield of the biopsy procedure and potential subsequent intervention, e.g. radiofrequency ablation.
- Regarding lung biopsies and lung ablation, potential increase of a database to refine image interpretation criteria with pathologists.
- In liver application, the goal is to build a database of images and define image interpretation criteria with pathologists to start image interpretation work.
- The predictive value of biopsies with Cellvizio assistance for lung or liver tumor biopsies.
For both applications, technical feedback from the physicians is expected on how they think the combined use of the devices could change the care path. E.g. a certain step in the workflow might become obsolete or the workflow could lead to fewer patient visits.
For the safety of this protocol, the use of endomicroscopy will not change in any way the patient management and standard procedure, including the diagnosis nor treatment decisions. All the adverse events / serious adverse events will be noted during the procedure and one week after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| addition of nCLE to help target biopsy | Other | Device: CT-guided percutaneous biopsy or ablationThe patient, scheduled for a liver or lung CT-guided percutaneous biopsy or ablation will undergo a probe-based confocal laser endomicroscopy procedure after the imaging procedure. The objectives of this study are to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure and determine whether it is technically feasible to obtain images from Cellvizio during an interventional radiology procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled to have an interventional radiology procedure for needle-biopsy or radiofrequency ablation purposes in lung or in liver, 18 years or older.
- Only subjects who have provided written informed consent for the study can be included in the study.
Key exclusion criteria (7 listed)
- Known allergy to fluorescein
- Previous life-threatening allergic reactions and known hypersensitivity to contrast media
- Pregnancy or breast-feeding
- History of cardio-pulmonary disease (including bronchial asthma)
- Restricted renal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-guided percutaneous biopsy or ablationStandard interventional radiology procedure for a biopsy or ablation in the liver or in the lung | Device | addition of nCLE to help target biopsy |
Primary outcome
Measure adverse events frequency in the use of mini probes on the tumor
Time frame: Up to 1 week
Assessment of the safety of inserting Cellvizio confocal miniprobe in the tumor (nor increase in bleeding or tumor cell dissemination) through the frequency, type and severity of adverse events
4 secondary outcomes
Creation of image bank
Time frame: Up to 6 months
Yield of nCLE (needle-based confocal laser endomicroscopy)-targeted Fluoroscopy-guided biopsies
Time frame: Up to 5 months
Evaluation of potential benefits of the device combination
Time frame: Up to 5 months
Assessment of accuracy and predictive value of interpretation criteria
Time frame: Up to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier PELLERIN principal investigator
HEGP, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-guided percutaneous biopsy or ablation in people with Lung Percutaneous Biopsy and Liver Percutaneous Biopsy, run by Mauna Kea Technologies at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure adverse events frequency in the use of mini probes on the tumor (time frame: Up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.