Clinical trial NCT03226535: Ultrasound-CT Fusion System for Interventional Radiology Procedures
Official title: Ultrasound-CT Fusion System for Interventional Radiology Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CT Guided Biopsy
CT Guided Drain Placement Within the Abdomen or Pelvis
CT Guided Injection of Muscle or Nerve Within the Pelvis
Keywords: Computer Assisted Instrument Guidance (CAIG)
Ultrasound-CT Fusion
Image Fusion
Clear Guide SCENERGY
Needle path
Needle Guidance
CT
Ultrasound
Lead sponsor: Clear Guide Medical
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
First posted: 2017-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research is to use the Clear Guide SCENERGY technology, an FDA approved Ultrasound-CT fusion imaging system, that allows the user to fuse CT images onto a real-time ultrasound that is being performed on the patient. This fusion system will be used to perform ultrasound guided needle placements for patients undergoing percutaneous CT guided needle-based intervention. This study will consist of 20 patients, 10 patients using the CGM SCENERGY US-CT system and 10 patients using guidance only. The primary goal of the study is to prove that the new imaging fusion system is comparable to using either CT or US guidance alone to guide needle placement.

Detailed description: A simple 20 patient study will be performed using the CG SCENERGY system. This fusion system will be used to perform image guided needle placements for patients undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis). Only patients who are already scheduled for a CT guided procedure will be screened. The study design is as follows:

* 10 patients will have their procedure performed using the CGM SCENERGY US-CT fusion system and 10 patients will have their procedure performed using CT guidance only.
* Proper informed consent will be obtained
* Perform a CT scan with the optical adhesive skin markers in place. Markers are placed around the expected site of needle skin entry.
* The first 10 patients Group#1 (1-10) will be assigned to using the SCENERGY fusion system to complete the needle placement, and the next 10 patients Group #2 (11-20) will be assigned of continuing with CT guidance only to complete the needle placement.
* If in Group #1, the procedure will proceed as usual using the SCENERGY system to guide the needle to target. If in the Group #2, CT guidance will be used to place the needle to target.
* Once the needle is at the target, a confirmatory CT will be performed.

  * If the target is reached (i.e., the software directed the interventional radiologist to the right place, e.g. for correctly biopsying a lesion), the trial is considered a "success" and the procedure continues as normal.
  * If the needle is not in the right place, the trial is considered a "failure", and the procedure continues as normal without using the CGM software any further.

Eligibility criteria: Inclusion Criteria:

* Undergoing percutaneous CT guided needle-based intervention (CT guided biopsy, CT guided drain placement within the abdomen or pelvis, and CT guided injection of muscle or nerve within the pelvis)
* Able to give written informed consent

Exclusion Criteria:

* Unable to give informed consent
* Patients undergoing CT guided needle-based interventions other than the procedures mentioned in the inclusion criteria
* Prisoners, pregnant women, and children

Primary outcomes:
measure: Number of CT scans or CT fluoroscopic images
timeFrame: Immediately following intervention (within 2 hours)
Secondary outcomes:
measure: Total procedure time
timeFrame: Immediately following intervention (within 2 hours)
measure: Time to target
timeFrame: Immediately following intervention (within 2 hours)
measure: Success of needle placement
timeFrame: Immediately following intervention (within 2 hours)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Brian Holly, MD
role: PRINCIPAL_INVESTIGATOR
References: