Recruiting

STING-MARK

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05465161

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sting Mark Fiducial Marker

Study Details

Brief summary:

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.

Conditions

Cancer

Study ID

NCT05465161

Start date

Feb 28, 2022

Status verified date

Mar, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing surgical resection of solid organs
  • Recipients of solid organ transplantation

Exclusion Criteria:

  • None

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: StingMark Fiducial Marker

Device 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.

Interventions

Sting Mark Fiducial Marker

Device 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.

Primary outcome measure

  • Gain experience with deployability of the device in multiple organs, through different needles and different routes of insertion (trans-cutaneous, endoscopic). [ Time Frame: Through study completion, an average of 1 year ]
  • Verify stability of the device once inserted. [ Time Frame: Through study completion, an average of 1 year ]
  • verify radio-opacity of the device following insertion. [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Moishe Liberman, MD

514-890-8000moishe.liberman@umontreal.ca

Locations

CHUM

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Moishe Liberman, MD

514-890-8000moishe.liberman@umontreal.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Apr 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-04-13.