STING MARK Fiducial Marker for Cancer

(StingMark Trial)

Overseen by Moishe Liberman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new device called STING-MARK, which helps doctors mark and locate tumors inside the body using x-rays. The device is tested on organs removed during surgeries or transplants. It aims to improve accuracy in finding tumors for better treatment.

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 data supports the effectiveness of the STING MARK Universal Fiducial Marker System treatment?

Fiducial markers, like those in the STING MARK system, are shown to improve the precision of radiation treatments by helping doctors accurately target tumors, as seen in studies involving prostate and liver cancers. This increased accuracy can potentially lead to better treatment outcomes. ^{1 2 3 4 5}

Research Team

Moishe Liberman, MD

Principal Investigator

CHUM

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• STING MARK Universal Fiducial Marker System (Fiducial Marker)

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Prospective evaluation of fiducial marker placement quality and toxicity in liver CyberKnife stereotactic body radiotherapy. [2021]

2. England 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. [2022]

3. Poland pubmed.ncbi.nlm.nih.gov

[Evaluation of GoldAnchorTM fiducial marker migration during the planning of radiation treatment for patients with prostate cancer]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The Feasibility and Utility of Cystoscopy-Guided Hydrogel Marker Placement in Patients With Muscle-Invasive Bladder Cancer. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

SU-E-J-205: Modeling Fiducial Marker Movement in Prostate. [2019]