Evaluating high dose radioembolization for large inoperable liver tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with large inoperable liver tumors, specifically those with at least one lesion larger than 5 cm. It aims to assess the safety and efficacy of Y90 high dose radioembolization, utilizing the AMARA principle to deliver a planned irradiated tumor dose greater than 200 Gy. The study will also correlate treatment outcomes with post-treatment dosimetry analysis using advanced imaging techniques. Participants will undergo various imaging procedures to monitor their condition and treatment response over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \>18 yr
* Both sexes eligible for study
* Patients with primary or secondary liver tumors
* Liver dominant disease
* At least one lesion greater than 5.0 cm in maximum diameter
* Life-expectancy \> 3 months
* FLR \>40% or greater than 500mls
* Must be able to tolerate pre-treatment CT scan , DSA and 99mTc-MAA infusion and imaging with SPECT/CT scan
* Able to schedule and tolerate post-treatment Y90 PET/CT imaging
* Able to tolerate follow-up imaging with dynamic contrast CT liver phase or MRI with liver specific contrast at 3mo, 6mo, 9mo, 1yr, 2.0 yr, and 3.0 years.

Exclusion Criteria:

* Child Pugh \> B
* Bilirubin \>2 mg/dl
* Albumin\<3.0
* Central portal invasion
* Multi-focal bilobar disease
* Disseminated extrahepatic disease
* Lung shunt \>20% or a estimated Lung dose \> 20 Gy
* Focuses of extra-hepatic liver uptake.
* Patients that cannot tolerate addition follow-up imaging.

Where it's running

• University Hospital of Patras
  Pátrai, Achaia, Greece Recruiting

Study contacts

• Study coordinator: Konstantinos Katsanos, Professor
• Email: katsanos@med.upatras.gr
• Phone: +306978225019

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• BGB-B2033 vs Sorafenib or Lenvatinib for advanced liver cancer

  This study tests whether the investigational drug BGB-B2033 can help people with advanced hepatocellular carcinoma when given after prior PD-1/PD-L1 therapy, compared with the standard medicines sorafenib or lenvatinib.

  Recruiting at 2 sites Phase 3 BeOne Medicines · South Brisbane, Queensland and 1 other locations · NCT07836530

• Protoacoustic Imaging to See Radiation Delivery in Proton Therapy

  This study tests radioacoustic imaging with ultrasound to help doctors see where proton therapy is delivering radiation for liver and prostate cancer patients.

  Recruiting University of Oklahoma · Oklahoma City, Oklahoma · NCT07832617

• YMN-136 vaccine for advanced liver, biliary tract, and pancreatic cancers

  A first-in-human dose-escalation study tests whether the YMN-136 vaccine is safe and tolerable for adults with unresectable advanced liver, biliary tract, or pancreatic cancers who have progressed on standard therapies or cannot receive them.

  Recruiting Phase 1 West China Hospital · Chengdu, Sichuan · NCT07763301

• DRAGON: International registry for patients who had combined portal and hepatic vein embolization before liver surgery

  This registry collects data on patients who had PVE/HVE before liver resection to see if it helps liver regeneration and what factors relate to outcomes.

  Recruiting at 30 sites Maastricht University Medical Center · Chicago, Illinois and 30 other locations · NCT07717437

• Precision navigation to boost cancer screening participation in high-risk communities

  This study tests whether a personalized navigation program helps adults aged 45–74 in Chinese communities who are at high risk for several cancers to complete recommended free cancer screenings.

  Recruiting at 3 sites Hunan Cancer Hospital · Huaihua, Hunan and 2 other locations · NCT07676383

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.