Y90 Microsphere Therapy for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Y90 Microsphere Therapy, a treatment targeting liver cancer that surgery cannot remove. The researchers aim to compare a new delivery method to a standard one to assess its effectiveness. The study seeks participants with liver tumors 3 cm or larger, with visible blood vessels feeding the tumor on scans. Participants must be eligible for Y90-radioembolization, a procedure delivering radiation directly to the tumor. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve future treatment options.
What prior data suggests that Y90 Microsphere Therapy is safe for liver cancer?
Previous studies have shown that Y90 microsphere therapy is quite safe for patients with liver cancer. Research indicates that patients generally tolerate this therapy well, with many experiencing only mild side effects. For example, one study found that this treatment was safe and effective for primary liver cancer and could even help some patients prepare for a liver transplant.
Another study reported that Y90 radioembolization is a safe option for patients with liver tumors who cannot undergo surgery. Additionally, the FDA has approved the treatment for liver cancer, highlighting its strong safety record. Overall, evidence supports that Y90 microsphere therapy is generally safe for patients.12345Why are researchers excited about this trial?
Y90 Microsphere Therapy is unique because it uses tiny radioactive beads to target liver cancer directly, offering a more focused treatment than traditional chemotherapy or surgery. Unlike conventional therapies that affect the whole body, this approach delivers radiation right to the tumor site, potentially reducing side effects and sparing healthy tissue. Researchers are excited about its precision and the potential for quicker, more effective results, which could significantly improve patient outcomes.
What evidence suggests that Y90 Microsphere Therapy might be an effective treatment for liver cancer?
Research shows that Y90 Microsphere Therapy is a promising treatment for liver cancer, particularly for patients with hepatocellular carcinoma (HCC) that cannot be surgically removed. Studies have found that this therapy can significantly extend survival times. Specifically, one study noted a median survival of up to 17 months for patients with a certain liver function level. Other reports highlight the therapy's effectiveness in targeting tumors, with some patients becoming eligible for surgery after treatment. Additionally, this therapy has helped patients prepare for liver transplants. Overall, Y90 Microsphere Therapy is considered a strong treatment option for advanced liver cancer, directly targeting the affected area.12678
Who Is on the Research Team?
Peiman Habibollahi, MD
Principal Investigator
M.D. Anderson Cancer Center
S. Cheenu Kappadath, PHD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Y90 Radioembolization using the TriNav Infusion System to evaluate alterations in CT-based tumor-to-normal liver ratio and tumor dose
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Y90 Microsphere Therapy
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Will show an increase of TNR and TD as well as a reduction in NTLD by TriNav microcatheter.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
TriSalus Life Sciences, Inc.
Industry Sponsor
Citations
Yttrium-90 microsphere therapy for hepatocellular carcinoma
The clinical outcomes of Y-90 microsphere therapy in patients with unresectable HCC have demonstrated promising results. Numerous studies have ...
Long-term outcome analysis of Y90 radioembolization in ...
Patients with CP class A (85%) had a median progression-free survival (PFS) of 3 months (95% CI: 2.99–5.55) and median OS of 17 months (95% CI: 9.59–23.10) from ...
Outcomes of Y90 Radioembolization for Hepatocellular ...
Median OS after first TAE was 29.3 months (15.3–58.9, 95% CI). Median OS after first TARE was 10.6 months (6.8–27.0, 95% CI). ECOG performance ...
Meta-analysis of efficacy and safety of Yttrium-90 ...
Transarterial radioembolization (TARE) using Yttrium-90 microspheres has emerged as a promising locoregional therapy for patients with advanced hepatocellular ...
Single-system outcomes after adopting yttrium-90 ...
Y with personalized dosimetry yields excellent target OR (98%) and CR (71%) rates in solitary, unresectable HCC. •. First cycle target CR led to a 14% ...
Safety and feasibility of yttrium-90 (Y-90) treatment for ...
We report safety/efficacy data on Y-90 therapy performed at a community hospital treating high volume of cancer patients. Methods: Multi- ...
Long-term Clinical Outcomes of Yttrium-90 Transarterial ...
Y90-TARE is a safe and effective therapy for primary HCC. Enduring outcomes further act as a realistic bridge to liver transplantation.
Radioembolization of Liver Tumors With Yttrium-90 ...
Two Y-90 microsphere products are commercially avail- able: TheraSphere (glass microspheres) was approved in. 1999 by the US FDA for the treatment of ...
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