Needle-based Confocal Laser Endomicroscopy in CT-guided Percutaneous Procedures

NCT ID: NCT02288104

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-03-17

Brief 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. 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:

1. Assess the safety of the use of Endomicroscopic imaging during interventional radiology procedure in two main indications: liver and kidney.

2. Assess the quality of biopsies performed with the help of Cellvizio.

3. 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.

Conditions

Liver Percutaneous Biopsy or Ablation; Kidney Percutaneous Biopsy or Ablation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

needle based confocal endomicroscopy

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.

Group Type: OTHER

needle based confocal endomicroscopy

Intervention Type: DEVICE

real time imaging of living tissue at microscopic scale, through a needle.

Interventions

needle based confocal endomicroscopy

real time imaging of living tissue at microscopic scale, through a needle.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mauna Kea Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Afshin Gangi

Role: PRINCIPAL_INVESTIGATOR

NHC, Strasbourg, France

Locations

Nouvel Hôpital Civil

Strasbourg, , France

Countries

France

Other Identifiers

MKT-IR-NHC-2014

Identifier Type: -

Identifier Source: org_study_id