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STING MARK Universal Fiducial Marker System

NCT ID: NCT05465161

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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Patients undergoing surgical resection of solid organs at the CHUM or recipients of solid organ transplantation will be approached for consent into the study protocol. Human solid organs that are being removed for either elective surgery or transplantation will be removed in the standard manner and sent to the pathology laboratory as in the typical situation following removal. After the pathology team finishes with the organ, excess organ will be given to the research team for experimentation. In cases of recipient organs being removed for transplantation, they will be preserved in a plastic bag and then placed in the refrigerator. All experimentation will take place in the CRCHUM TID lab or Room 13 of the CHUM operating room.

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.

Following experimentation, the organs will be appropriately labelled and returned to the pathology laboratory at the CHUM.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sting Mark Fiducial Marker

Intervention Type DEVICE

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

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moishe Liberman, MD

Role: PRINCIPAL_INVESTIGATOR

CHUM

Locations

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CHUM

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Moishe Liberman, MD

Role: CONTACT

Phone: 514-890-8000

Email: [email protected]

Facility Contacts

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Moishe Liberman, MD

Role: primary

Other Identifiers

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CE 21.203

Identifier Type: -

Identifier Source: org_study_id