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Brachytherapy

SIR-Spheres® Radiotherapy for Uveal Melanoma

Phase 2
Waitlist Available
Led By Takami Sato, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have one measurable untreated or progressed liver lesion with less than 50% liver involvement
Must have diagnosis of metastatic melanoma liver disease by histological confirmation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post treatment
Awards & highlights

Study Summary

This trialtests if radiation can kill tumor cells by targeting the blood vessels around them.

Who is the study for?
This trial is for adults with uveal melanoma that has spread to the liver. Participants must have at least one measurable liver lesion, good liver and kidney function, no prior specific treatments like hepatic perfusion or recent chemotherapy, and an ECOG performance status of 0-1 indicating they are fully active or restricted in physically strenuous activity.Check my eligibility
What is being tested?
The study tests if SIR-Spheres®, tiny radioactive beads delivered directly into the liver's blood vessels, can shrink tumors in patients with eye melanoma that has spread to the liver. The treatment aims to kill tumor cells by providing targeted radiation.See study design
What are the potential side effects?
Potential side effects may include abdominal pain or discomfort, nausea, fever, fatigue due to radiation exposure; there could also be risks associated with the procedure such as infection or damage to non-targeted organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You need to have a liver lesion that can be measured and has not been treated before, and it should not involve more than half of the liver.
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You need to have been diagnosed with advanced melanoma that has spread to the liver and the diagnosis has been confirmed by tissue testing.
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You should be in good physical shape with no or minimal impact on daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical benefit rate of previously treated and naive patients
Number of patients with adverse events
Secondary outcome measures
Duration of Response
Overall Survival
Progression Free Survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sirspheres, response evaluationExperimental Treatment1 Intervention
Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,863 Total Patients Enrolled
Takami Sato, MDPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
236 Total Patients Enrolled
Carin Gonsalves, MDPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
578 Total Patients Enrolled

Media Library

Sir-Spheres® (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01473004 — Phase 2
Uveal Melanoma Research Study Groups: Sirspheres, response evaluation
Uveal Melanoma Clinical Trial 2023: Sir-Spheres® Highlights & Side Effects. Trial Name: NCT01473004 — Phase 2
Sir-Spheres® (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01473004 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks are associated with Sir-Spheres® administration?

"Our in-house team at Power has rated Sir-Spheres®' safety as a 2; it is currently undergoing Phase 2 trials, providing evidence of its security but not yet confirming any efficacy."

Answered by AI

Is this research endeavor currently accepting participants?

"Clinicaltrials.gov confirms that this medical trial, initially posted on October 31 2011 and last updated in December 20 2022, is not enrolling new patients at the moment. However, there are still 761 other studies recruiting participants presently."

Answered by AI
~4 spots leftby Mar 2025