Biopsy or Ablation Procedures
Conditions
Keywords
biopsy guidance, tracking device
Brief summary
This prospective, randomized, controlled, parallel-design trial will compare the use of electromagnetic tracking and image guidance during biopsy/ablation procedures verses the typical standard or conventional image guided procedure alone (control). US ultrasound-guided biopsies/ablations with or without CT computed tomography- imaging will be used to complete the procedures in either the CT suite or a procedure room, at the discretion of the physician, and according to normal local practice patterns.
Detailed description
The study will consist of approximately 300 patients from 1 sites. Each site will have a study group, where the physician will use the electromagnetic tracking system along with US ultrasound or CT computed tomography to complete the procedure and a control group, where the electromagnetic tracking system will be used, but the physician will be blinded to it and use only the typical, standard, conventional protocol, using US or CT, to complete the procedure. The expected completion time for enrollment is 12 months, but will depend on the ability of each Clinic to enroll patients. Data and observations will be collected at a total of 2 scheduled appointments (screening and 1 study visit) or based on the current hospital workflow, which may combine these into one patient encounter.
Interventions
None listed
Sponsors
Philips Healthcare
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has had a pre-operative CT scan performed and will be undergoing a biopsy or ablation procedure of the chest, abdomen and/or pelvis; * Is over the age of 18; * Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol; * Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure.
Exclusion criteria
* Was precluded from a biopsy/ablation procedure based on standard exclusions; * Has an adhesive allergy (due to the application of active fiducials with adhesive backing); * Has a pacemaker or automatic implantable cardiac defibrillator; * Has a gross body weight above the procedural table limit (typically \> 170 kg); * Is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Registration Error | Day 1 | TRE Target Registration Error (distance between virtual needle position (tracking data) and the actual needle position (CT Computed Tomography confirmation scan)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success of ablation as determined by imaging | 3 months | Primary effectiveness (success of ablation in local tumor control or success of biopsy in diagnostic biopsy sample). Successful ablation equals complete tumor ablation with a 5mm-1cm margin of normal tissue (if possible; quantified by the lack of enhancement of intravenous contrast material at 3 month follow up CT). |
Countries
United States
Outcome results
None listed