STING MARK Universal Fiducial Marker System
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
Currently available fiducial marker and fiducial insertion strategies are rudimentary, imprecise, not compatible with multiple insertion catheters/needles and are overall unreliable. STING-MARK device is the first universal, fully detachable and non-premounted radiopaque fiducial device system. Allowing biopsy prior to insertion, STING-MARK is easily and reliably delivered through-the-needle to the tumor, in order to accurately pinpoint its location for image-guided therapies. This study aims at establishing proof of concept for STING-MARK, by demonstrating its usability, reproducibility, radio-opacity and retention in a variety of clinically-relevant ex vivo organ samples.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing surgical resection of solid organs
Recipients of solid organ transplantation
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Sting Mark Fiducial Marker
DeviceDevice insertion will occur with the designated needles and through the appropriate organ-specific route and imaging guidance. Multiple STING-MARK fiducials will be inserted. Plain film x-rays in 3 planes of the organs with the marker inserted will be taken and recorded.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: StingMark Fiducial MarkerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gain experience with deployability of the device in multiple organs, through different needles and different routes of insertion (trans-cutaneous, endoscopic).
1\) The deployability of the device will be measured with a deployability performance score (3=best over all metrics, 9=worst over all metrics) and compared with that of competing devices (Ultra EchoTip, Lumicoil) tested in parallel by the same user(s). No health outcomes are used in this score. Metrics used to establish this score are : operational efficiency ratio (the number of occurences of proper travel/anchoring/detaching over the total number of trials), time of operation and number of steps (from the first handling of the device to its detachment or lack thereof). Tests will be conducted on different organ locations (lung, oseophagus) with different routes of insertion (trans-cutaneous, endoscopic) using different models of 22Ga biopsy needles.
Time frame
Through study completion, an average of 1 year2
Verify stability of the device once inserted.
2\) The stability of the device after insertion will be measured with a stability performance score (3=best over all metrics, 9=worst over all metrics) and compared with that of competing devices (Ultra EchoTip, Lumicoil) tested in parallel by the same user(s). No health outcomes are used in this score. Metrics used to establish this score are mean three-dimensional fiducial displacement and maximal unidirectional displacement (along with its axis). These metrics are calculated by constructing a displacement vector map based on X-ray images of marker position relative to each other and to key neighbouring biological structures (tumor, bones, organs, other markers) taken each day over a period of 3 days.
Time frame
Through study completion, an average of 1 year3
verify radio-opacity of the device following insertion.
3\) The radio-opacity of the device after insertion will be measured with a stability performance score (4=best over all metrics, 12=worst over all metrics) and compared with that of competing devices (Ultra EchoTip, Lumicoil) tested in parallel by the same user(s). No health outcomes are used in this score. Metrics used to establish this score are : visual identification by surgeons and radiologists (based on their expertise by a simple yes/no criterion), automated radiotherapy machine software detection (based on the built-in detection criterion), mean pixel intensity and signal-to-noise ratio (from computer-based image analysis). These metrics are measured on MRI/X-ray/CT-scan images taken right after insertion and 1 day after insertion.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
User feedback regarding usability of the device
Throughout all previsouly measured ouctomes, users will be asked to fill standard usability questionnaire SUS (10 questions, 0-100 score, \>68 being considered above average). At the end of the experiments, users will be asked to fill a post-study usability questionnaire PSSUQ (16 questions, 1-7 score for each question, the lower the score, the better the performance and satisfaction).
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov