STING MARK Fiducial Marker for Cancer

(StingMark Trial)

Recruiting at 1 trial location

Overseen By Moishe Liberman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the STING-MARK Universal Fiducial Marker System, which helps doctors precisely locate tumors during image-guided treatments. The device aims to be easy to use and reliable, improving on current methods that are often inaccurate. Participants in this study will help demonstrate the device's effectiveness in identifying tumors. The trial seeks individuals undergoing surgery to remove solid organs or who have received a solid organ transplant. As an unphased trial, it offers participants the chance to contribute to advancements in medical technology that could enhance surgical precision.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the STING-MARK device is safe for use in image-guided therapies?

Research shows that the STING MARK Universal Fiducial Marker System can be safely placed in the body using regular biopsy needles. Previous studies found that this system is easy to use and compatible with various needle types. The device aids doctors in marking and locating tumors more accurately with x-rays.

Although specific data on side effects is not available, its testing in clinical trials suggests an expectation of safety. This trial primarily focuses on the device's effectiveness rather than its side effects. While no safety issues have been reported, participants should discuss any concerns with the medical team involved in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STING MARK Universal Fiducial Marker System because it offers a new way to precisely locate and target cancerous tumors during treatment. Unlike standard fiducial markers, which may not be as versatile or accurate across different organs, STING MARK is designed for universal use with organ-specific routes and imaging guidance, potentially improving precision. This system could enhance the accuracy of treatments like radiation therapy by ensuring that the therapy is delivered exactly where it's needed, minimizing damage to surrounding healthy tissues.

What evidence suggests that the STING-MARK device is effective for accurately pinpointing tumor locations?

Research has shown that fiducial markers, such as those in the STING MARK system, help doctors aim radiation treatments more precisely at tumors. In this trial, participants will receive the STING MARK, a new type of marker that is easy to see on X-rays and can be placed directly into the tumor using a needle. This system also allows doctors to take a small tissue sample, called a biopsy, before placing the marker. Early results suggest that this could enhance the accuracy and effectiveness of image-guided cancer treatments. ^{1 2 3 5 6}

Who Is on the Research Team?

Moishe Liberman, MD

Principal Investigator

CHUM

Are You a Good Fit for This Trial?

This clinical trial is open to individuals who have received solid organ transplants or are undergoing surgical removal of solid organs. There are no specific exclusion criteria mentioned, so it appears to be broadly accessible.

Inclusion Criteria

Recipients of solid organ transplantation

I am scheduled for surgery to remove a solid organ.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Insertion and Imaging

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.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for device stability and radio-opacity through imaging over a period of 3 days.

1 week

3 visits (in-person)

Data Analysis and Feedback

Analysis of imaging data and user feedback regarding the usability and deployability of the device.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• STING MARK Universal Fiducial Marker System

Trial Overview

The STING MARK Universal Fiducial Marker System is being tested for its ability to mark tumors accurately in patients with cancer. It's a new type of marker that can be delivered precisely and is visible on imaging scans, intended to improve the targeting for image-guided therapies.

How Is the Trial Designed?

Group I: StingMark Fiducial Marker Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Fiducial markers used for prostate positioning can migrate by more than 2 mm, which may affect the accuracy of patient positioning during treatment, especially in techniques like stereotactic body radiation therapy (SBRT).

The study developed an optimal registration algorithm that showed minimal patient setup error, averaging around 1.10 mm, but highlighted that small registration errors do not necessarily indicate good patient positioning due to potential marker migration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SU-E-J-205: Modeling Fiducial Marker Movement in Prostate. Yao, W., Corsten, M.[2019]

Fiducial marker placement for primary liver tumors in patients with hepatocellular carcinoma is generally safe, with a high quality of placement achieved in 93% of cases by experienced practitioners, compared to only 30% in earlier cohorts.

Complications and longer recovery times are more likely in patients with poor performance status and during the learning curve of the procedure, highlighting the importance of experience in minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of fiducial marker placement quality and toxicity in liver CyberKnife stereotactic body radiotherapy. Dutta, D., Kataki, KJ., George, S., et al.[2021]

In a study of 29 patients undergoing image-guided radiation therapy, GoldAnchorTM fiducial markers implanted in the prostate showed minimal migration, averaging 0.17 cm, which is likely not clinically significant for treatment accuracy.

The research suggests that while some marker movement occurs during treatment planning, timely initiation of radiation therapy and continuous monitoring of marker position can help maintain treatment precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of GoldAnchorTM fiducial marker migration during the planning of radiation treatment for patients with prostate cancer]. Bodusz, D., Głowacki, G., Leszczyński, W., et al.[2019]

In a study of nine patients with recurrent prostate cancer, the presence and type of fiducial markers significantly affected the effectiveness of MR-guided transurethral ultrasound ablation (TULSA), with 70% of markers allowing for successful thermal dose accumulation to the target area.

Gold markers caused less disruption to treatment compared to nitinol markers, which created large artifacts that interfered with temperature measurements, highlighting the importance of careful selection and placement of markers to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fiducial markers and their impact on ablation outcome for patients treated with MR-guided transurethral ablation (TULSA): a retrospective technical analysis. Wright, C., Mäkelä, P., Anttinen, M., et al.[2022]

The study demonstrated that cystoscopy-guided placement of hydrogel markers in 32 patients with muscle-invasive bladder cancer is safe, with no procedure-related adverse events reported.

While 76.6% of the markers were sufficient for tumor delineation at the start, only 46.7% remained visible and adequate for routine verification by the end of treatment, indicating a need for improvement in marker performance during radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility and Utility of Cystoscopy-Guided Hydrogel Marker Placement in Patients With Muscle-Invasive Bladder Cancer. Wortel, K., Hovius, MC., van Andel, G., et al.[2020]

Citations

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clinicaltrials.gov/study/NCT05465161

STING MARK Universal Fiducial Marker System (StingMark)

STING-MARK device is the first universal, fully detachable and non-premounted radiopaque fiducial device system. Allowing biopsy prior to insertion, STING-MARK ...

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clinicaltrial.be

clinicaltrial.be/en/details/192077?per_page=100&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

STING MARK Universal Fiducial Marker System - Clinical Tr...

1) The deployability of the device will be measured with a deployability performance score (3=best over all metrics, 9=worst over all metrics) ...

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withpower.com

withpower.com/trial/phase-malignancies-9-2022-26eeb

STING MARK Fiducial Marker for Cancer (StingMark Trial)

Fiducial markers, like those in the STING MARK system, are shown to improve the precision of radiation treatments by helping doctors accurately target tumors, ...

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trialx.com

trialx.com/clinical-trials/listings/279697/sting-mark-universal-fiducial-marker-system/

STING MARK Universal Fiducial Marker System

Allowing biopsy prior to insertion, STING-MARK is easily and reliably delivered through-the-needle to the tumor, in order to accurately pinpoint ...

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app.trialscreen.org

app.trialscreen.org/trials/cancer-sting-mark-universal-fiducial-marker-system-trial-nct05465161

STING MARK Universal Fiducial Marker System

However, the study aims to evaluate a new marker system that could potentially improve the accuracy and effectiveness of image-guided cancer therapies, ...

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aats.org

aats.org/resources/abstract.pdf?abstract=2939821

StingMark : Validation of a Novel Universal, User-friendly, ...

Conclusions: StingMark is a new through-the-needle, user-friendly, disposable fiducial marker system compatible with any off-the-shelf biopsy needle or ...