What side effects are associated with this type of intervention?

Common treatments for cancer, such as radiation therapy, chemotherapy, and targeted therapies, have a range of side effects. Radiation therapy can cause skin irritation, fatigue, and localized pain. Chemotherapy often leads to nausea, vomiting, hair loss, and increased susceptibility to infections due to lowered blood cell counts. Targeted therapies, which include drugs like pembrolizumab and cetuximab, can cause side effects such as rash, diarrhea, and fatigue. These treatments aim to manage and reduce tumor size but come with varying degrees of adverse effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several advanced imaging and localization technologies for cancer treatment. One notable example is lutetium Lu 177 vipivotide tetraxetan, approved for PSMA-positive metastatic castration-resistant prostate cancer (CRPC). This radioligand therapy uses a PSMA-11 diagnostic assay for precise tumor targeting. Additionally, various radiopharmaceuticals and fiducial markers have been approved to enhance the accuracy of radiation therapy and surgical interventions, ensuring precise localization and treatment of tumors.

What other types of research exist?

Promising alternatives to the STING-MARK device for accurate tumor localization in cancer patients include: 1) Cyberknife Synchrony Respiratory Tracking System, which uses a single fiducial marker for precise tracking of moving tumors, particularly in the lungs and heart. 2) Proton beam irradiation systems, which offer high precision in targeting tumors, especially those in challenging locations like the liver and lungs. These systems are supported by growing evidence of their efficacy in local control and survival rates.

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STING MARK Fiducial Marker for Cancer (StingMark Trial)

N/A

Recruiting

Led By Moishe Liberman, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a fiducial marker system rather than a drug, traditional side effects may not apply. However, potential risks could include discomfort at the insertion site or issues related to incorrect placement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gain experience with deployability of the device in multiple organs, through different needles and different routes of insertion (trans-cutaneous, endoscopic).

Medical Devices

verify radio-opacity of the device following insertion.

Secondary study objectives

User feedback regarding usability of the device

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: StingMark Fiducial MarkerExperimental Treatment1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery physically removes tumors, radiation therapy uses high-energy particles to damage DNA in cancer cells, and chemotherapy employs drugs to kill rapidly dividing cells. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. Accurate tumor localization, as facilitated by devices like the STING-MARK fiducial marker system, is essential for precisely targeting these treatments, minimizing damage to healthy tissues, and improving outcomes for cancer patients.