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Radioembolization

Radioembolization for Liver Cancer

Phase 1
Waitlist Available
Led By Armeen Mahvash
Research Sponsored by M.D. Anderson Cancer Center
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 up to 6 months
Awards & highlights

Study Summary

This trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with metastatic liver cancer.

Who is the study for?
This trial is for patients with liver cancer that has spread, who can understand and sign a consent form. It's suitable for those eligible for standard Y90 radioembolization treatment but not for patients where the cancer affects more than half of the liver.Check my eligibility
What is being tested?
The study tests yttrium Y-90 radioembolization, which involves injecting radioactive particles into an artery to block blood flow to liver tumors. The focus is on doing this in one session to see if it's effective and more efficient.See study design
What are the potential side effects?
Possible side effects include abdominal pain, nausea, fever, fatigue, and potential complications from radiation like damage to nearby organs or tissues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Angiogram

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (angiography, yttrium Y-90 radioembolization)Experimental Treatment7 Interventions
The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging. All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiography
2014
N/A
~1900
Technetium Tc-99m Albumin Aggregated
2014
Completed Phase 2
~70
Computed Tomography
2017
Completed Phase 2
~2720
Radioembolization
2020
Completed Phase 2
~30
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,924,605 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,790 Total Patients Enrolled
22 Trials studying Liver Cancer
9,411 Patients Enrolled for Liver Cancer
Armeen MahvashPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
341 Total Patients Enrolled

Frequently Asked Questions

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

Does this particular therapeutic method have the seal of approval from the FDA?

"With limited data to draw from, the perceived safety of this treatment is a 1 on our internal scale. As it stands, this Phase 1 trial has only provided preliminary evidence regarding its efficacy and potential adverse effects."

Answered by AI

Is this experiment currently recruiting participants?

"According to information available on clinicaltrials.gov, this medical investigation is not currently enlisting participants, as the trial was last updated on September 22nd 2022 and has since concluded recruitment efforts. However, there are 775 other active research studies looking for test subjects at present time."

Answered by AI
~1 spots leftby Jan 2025