Liver Percutaneous Biopsy or AblationNCT02288104
Needle-based Confocal Laser Endomicroscopy in CT-guided Percutaneous Procedures
A study testing needle based confocal endomicroscopy in people with Liver Percutaneous Biopsy or Ablation and Kidney Percutaneous Biopsy or Ablation, 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: Kidneys 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
- Liver Percutaneous Biopsy or Ablation, Kidney Percutaneous Biopsy or Ablation
- What is being tested?
- needle based confocal endomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to 17 Mar 2017
- 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 liver or Kidney.
- Only subjects who have provided written informed consent for the study can be included in the study.
Who cannot join
- Patients have a known allergy to fluorescein
- Patient is Pregnant or breast-feeding
- Patient under judiciary control
- Patient under the tutelage of a guardian
- Patient unable to sign the information consent form (in case of an emergency situation or difficulty in understanding the information)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Needle-based Confocal Laser Endomicroscopy in CT-guided Procedures in Interventional Radiology With Applications in Liver and Kidneys: 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: Kidneys 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: liver and kidneys.
The Primary objective is:
To study and demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: liver and kidney.
The Secondary objectives are:
- Assess the safety of the use of Endomicroscopic imaging during interventional radiology procedure in two main indications: liver and kidney.
- Assess the quality of biopsies performed with the help of Cellvizio.
- Build a database of images as an atlas and define image interpretation criteria in collaboration with pathologists.
Evaluate whether and how Cellvizio can improve guidance for biopsies or ablations: for instance, in the critical structures such as nerves or vessels in the vicinity of the cryoablation area, is it possible to visualize ice crystals and therefore decide to stop the cryoablation at the right time/location?
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
- needle based confocal endomicroscopy
- Keywords
- Interventional Radiology, Liver, Kidney, 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.
needle based confocal endomicroscopyDevice
real time imaging of living tissue at microscopic scale, through a needle.
| Study group | Role | What they receive |
|---|---|---|
| needle based confocal endomicroscopy | Other | The patient, scheduled for a standard liver or kidney percutaneous biopsy or ablation will undergo a needle-based confocal laser endomicroscopy procedure during the 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: needle based confocal endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy (sensitivity specificity) of endomicroscopy as compared to histopathology
Assessment of the accuracy of Cellvizio confocal mini probe imaging guided by fluoroscopy at the tumor boundary compared with traditional histopathology from physical biopsies
Measured: up to 2 weeks
Secondary outcomes (4)
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
Classification of endomicroscopy images from benign and malignant conditions
A first creation of an atlas of endomicroscopic images obtained in interventional radiology with corresponding correlation with traditional pathology images
Measured: Up to 6 months
Percentage of biopsies guided by nCLE (needle-based Confocal Laser Endomicroscopy) which provide a definitive diagnosis as a measure of efficiency of endomicroscopy-targeted biopsies compared to traditional needle 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
Number of patients for whom endomicroscopy could have affected the clinical workflow
Evaluation of the potential impact of the endomicroscopic information used in conjunction with the Siemens SOMATOM Definition system in clinical decision-making for each patient
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 posted11 Nov 2014 (estimated)
- Study startJan 2015
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Percutaneous Biopsy or AblationStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mauna Kea Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Afshin Gangi, Principal investigator, NHC, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288104
- Sponsor's protocol ID
- MKT-IR-NHC-2014
- Status last verified
- Aug 2017
- First submitted
- 27 Oct 2014
- Last updated
- 29 Aug 2017
- 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 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needle-based Confocal Laser Endomicroscopy in CT-guided Procedures in Interventional Radiology With Applications in Liver and Kidneys: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02288104
- Acronym / sponsor ID
- MKT-IR-NHC-2014
- Keywords
- Interventional Radiology, Liver, Kidney, Confocal endomicroscopy, Optical Biopsy, Scanner, Fluoroscopy, CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mauna Kea TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 11 Nov 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: Kidneys 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: liver and kidneys.
The Primary objective is:
To study and demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: liver and kidney.
The Secondary objectives are:
- Assess the safety of the use of Endomicroscopic imaging during interventional radiology procedure in two main indications: liver and kidney.
- Assess the quality of biopsies performed with the help of Cellvizio.
- Build a database of images as an atlas and define image interpretation criteria in collaboration with pathologists.
Evaluate whether and how Cellvizio can improve guidance for biopsies or ablations: for instance, in the critical structures such as nerves or vessels in the vicinity of the cryoablation area, is it possible to visualize ice crystals and therefore decide to stop the cryoablation at the right time/location?
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 |
|---|---|---|
| needle based confocal endomicroscopy | Other | Device: needle based confocal endomicroscopyThe patient, scheduled for a standard liver or kidney percutaneous biopsy or ablation will undergo a needle-based confocal laser endomicroscopy procedure during the 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 liver or Kidney.
- Only subjects who have provided written informed consent for the study can be included in the study.
Key exclusion criteria (5 listed)
- Patients have a known allergy to fluorescein
- Patient is Pregnant or breast-feeding
- Patient under judiciary control
- Patient under the tutelage of a guardian
- Patient unable to sign the information consent form (in case of an emergency situation or difficulty in understanding the information)
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 |
|---|---|---|
| needle based confocal endomicroscopyreal time imaging of living tissue at microscopic scale, through a needle. | Device | needle based confocal endomicroscopy |
Primary outcome
Diagnostic accuracy (sensitivity specificity) of endomicroscopy as compared to histopathology
Time frame: up to 2 weeks
Assessment of the accuracy of Cellvizio confocal mini probe imaging guided by fluoroscopy at the tumor boundary compared with traditional histopathology from physical biopsies
4 secondary outcomes
Measure adverse events frequency in the use of mini probes on the tumor
Time frame: Up to 1 week
Classification of endomicroscopy images from benign and malignant conditions
Time frame: Up to 6 months
Percentage of biopsies guided by nCLE (needle-based Confocal Laser Endomicroscopy) which provide a definitive diagnosis as a measure of efficiency of endomicroscopy-targeted biopsies compared to traditional needle biopsies
Time frame: Up to 5 months
Number of patients for whom endomicroscopy could have affected the clinical workflow
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 29 Aug 2017.
- Individual participant dataSharing planned: No
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.
Afshin Gangi principal investigator
NHC, Strasbourg, 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 needle based confocal endomicroscopy in people with Liver Percutaneous Biopsy or Ablation and Kidney Percutaneous Biopsy or Ablation, 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 5 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 29 Aug 2017. 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?
Diagnostic accuracy (sensitivity specificity) of endomicroscopy as compared to histopathology (time frame: up to 2 weeks). 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 29 Aug 2017.