Clinical trial NCT02288104: Needle-based Confocal Laser Endomicroscopy in CT-guided Percutaneous Procedures
Official title: Needle-based Confocal Laser Endomicroscopy in CT-guided Procedures in Interventional Radiology With Applications in Liver and Kidneys: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Percutaneous Biopsy or Ablation
Kidney Percutaneous Biopsy or Ablation
Keywords: Interventional Radiology
Liver
Kidney
Confocal endomicroscopy
Optical Biopsy
Scanner
Fluoroscopy
CT
Computed Tomography
Radiofrequency Ablation
Fluorescein
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Diagnostic accuracy (sensitivity specificity) of endomicroscopy as compared to histopathology
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Measure adverse events frequency in the use of mini probes on the tumor
timeFrame: Up to 1 week
measure: Classification of endomicroscopy images from benign and malignant conditions
timeFrame: Up to 6 months
measure: 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
timeFrame: Up to 5 months
measure: Number of patients for whom endomicroscopy could have affected the clinical workflow
timeFrame: Up to 5 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
Study officials:
affiliation: NHC, Strasbourg, France
name: Afshin Gangi
role: PRINCIPAL_INVESTIGATOR
References: