NCT04926376Completed
Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
Source: ClinicalTrials.gov · Last updated 29 Nov 2024
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety of treatment with Eye90 microspheres in patients with unresectable Hepatocellular Carcinoma (HCC) and metastatic Colorectal Cancer (mCRC). Both cause tumors, known as malignant hyper-vascular hepatic neoplasia, that have an abnormally large number of blood vessels attached to them. Eye90 is internal radiation brachytherapy for treatment of malignant hyper-vascular hepatic neoplasia that uses microspheres, tiny glass beads smaller in diameter than a human hair, to provide radiation. The microspheres contain Yttrium-90 (Y90) as the radiation source, which are used to to kill cancer cells and shrink tumors. The microspheres are also radiopaque, which means that they can be seen during imaging procedures. The visibility of the microspheres allows the study doctor to confirm the microspheres have been delivered in the tumor; this may help to improve the outcome of treatment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 9 Jun 2021
- Start date
- 2 Nov 2021
- Primary completion date
- 13 Nov 2023
- Lead sponsor
- ABK Biomedical
- NCT number
- NCT04926376
What you commit to
- Study type: Interventional
- Participants enrolled: 8
- From 2 Nov 2021 to the primary completion date, 13 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater
Other illness
- Portal vein thrombosis (PVT).
Lab values
- Hemoglobin ≤ 85 mg/L.
- Platelet count \< 50,000/microliter or prothrombin (PT) activity \> 50% normal
- INR \> 1.4 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
- ALT \> 2.5x upper limit
- AST \> 2.5x upper limit
- For HCC subjects, Bilirubin ≥ 2 mg/dL.
- For mCRC subjects, Bilirubin ≥ 1.2 mg/dL.
- eGFR ≤ 60 mL/min/1.73 m2.
Other
- Estimated lung dose \> 30 Gy as calculated using the lung shunt % and partition model.
Who the study is looking for
- Measurable disease defined as at least one unidimensional measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI).
- Must have at least one lesion \> 2 cm within the target perfused volume.
- At least one lesion must meet the definition of target lesion as defined by RECIST 1.1 or mRECIST.
- Total linear length of all lesions must be ≤ 9 cm.
- Must have preservation of \>700cc of normal liver parenchyma outside of treated volume.
- Hypervascular lesions on CT scan with 99mTC MAA SPECT/CT T:N ratio 3:1 or higher and Hypervascular on CBCT.
- No prior locoregional therapies in the liver other than previous Drug Eluting Bead TACE and/or local HCC recurrence after thermal ablation. Last TACE and/or ablation treatment must be at least 3 months prior to informed consent. Prior Lumi or Lipiodol TACE is not allowed.
- Life expectancy of ≥ 6 months.
- ≥ 18 years old.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Auckland District Health Board Coordinator of this site? Confirm its status | Grafton | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.