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Human Albumin As Macroaggregates

This article discusses a clinical trial investigating the use of Human Albumin As Macroaggregates in combination with other treatments for patients with non-resectable hepatocellular carcinoma (HCC). The study, known as HOLMBRAVE, aims to evaluate the safety and efficacy of selective intra-arterial 166Holmium radiation therapy combined with atezolizumab and bevacizumab for patients with this challenging form of liver cancer.

Table of Contents

What is Human Albumin as Macroaggregates?

Human Albumin as Macroaggregates is a medical product used in diagnostic imaging procedures. It is a component of a radiopharmaceutical preparation kit called Pulmocis 2 mg[1]. This substance is derived from human albumin, a protein naturally found in blood, which has been processed to form larger particles or aggregates.

How is it used?

Human Albumin as Macroaggregates is primarily used in lung imaging. It is combined with a radioactive substance called Technetium-99m to create a diagnostic tool. When injected into the bloodstream, these macroaggregates temporarily lodge in the small blood vessels of the lungs, allowing for detailed imaging of lung blood flow[1].

Medical Conditions

While the primary use of this product is for lung imaging, it’s important to note that in the clinical trial described, it is being investigated for a different purpose. The trial is exploring its use in patients with non-resectable Hepatocellular carcinoma (HCC), which is a type of liver cancer that cannot be surgically removed[1].

This highlights an interesting aspect of medical research: sometimes, products originally designed for one purpose (in this case, lung imaging) are investigated for potential benefits in treating other conditions (like liver cancer).

Administration

Human Albumin as Macroaggregates is administered through intravenous injection. This means it is injected directly into a vein, allowing it to circulate quickly throughout the body[1].

Dosage

The dosage is measured in a unit called MBq (megabecquerel), which is used to measure radioactivity. The maximum daily dose and maximum total dose mentioned in the trial information is 200 MBq[1]. However, it’s important to note that the exact dosage would be determined by a healthcare professional based on individual patient factors and the specific purpose of the imaging study.

Safety Considerations

As with any medical procedure involving radiation, there are some safety considerations to keep in mind:

  • This product is used under careful medical supervision.
  • It’s not suitable for everyone. For example, pregnant or breastfeeding women would typically not be given this product[1].
  • Patients with allergies to any components of the product should inform their healthcare provider.
  • The radiation exposure is generally considered low and short-lived, but it’s always balanced against the medical benefit of the procedure.

It’s crucial to remember that while this article provides general information about Human Albumin as Macroaggregates, its use in the mentioned clinical trial for liver cancer is investigational. Always consult with a healthcare professional for medical advice tailored to your specific situation.

Aspect Details
Study Name HOLMBRAVE
Main Objective Evaluate the added value of 166Holmium SIRT to Atezolizumab + Bevacizumab for non-resectable HCC
Key Inclusion Criteria Adults with non-resectable HCC, BCLC stage C, eligible for Atezolizumab and Bevacizumab therapy
Key Exclusion Criteria Complete main portal vein thrombosis, daily oxygen requirement, previous liver radiation therapy
Primary Endpoint Objective response rate at 6 months after 166Holmium SIRT
Secondary Endpoints Response rates, progression-free survival, overall survival, adverse events
Use of Human Albumin As Macroaggregates Part of radiopharmaceutical preparation for imaging purposes

FAQ

  • What is the main purpose of the HOLMBRAVE clinical trial? The main purpose of the HOLMBRAVE clinical trial is to evaluate the added value of 166Holmium SIRT (Selective Internal Radiation Therapy) when combined with Atezolizumab and Bevacizumab for patients with non-resectable hepatocellular carcinoma (HCC).
  • Who is eligible to participate in this clinical trial? Eligible participants are men and women aged 18 or older with pathologically confirmed, non-resectable hepatocellular carcinoma (HCC) classified as Barcelona Clinic Liver Cancer (BCLC) stage C. They must be eligible for first-line Atezolizumab and Bevacizumab combination therapy and have adequate organ function.
  • What is Human Albumin As Macroaggregates used for in this trial? Human Albumin As Macroaggregates is used as part of a radiopharmaceutical preparation called Pulmocis. In this trial, it is likely used for imaging purposes to help guide the delivery of the 166Holmium radiation therapy to the liver tumors.
  • What are the main outcomes being measured in this trial? The primary outcome is the objective response rate (complete or partial response) at 6 months after 166Holmium SIRT. Secondary outcomes include response rates, progression-free survival, overall survival, and the frequency and severity of treatment-related adverse events.
  • Are there any specific exclusion criteria for this trial? Yes, there are several exclusion criteria. Some key ones include: complete main portal vein thrombosis, requirement for daily supplemental oxygen, previous external radiation therapy to the liver, and certain medical conditions such as uncontrolled hypertension or recent major cardiovascular events.

Ongoing Clinical Trials on Human Albumin As Macroaggregates

  • Comparing Lung Perfusion PET/CT-Guided Versus Standard Planning for Stereotactic Body Radiotherapy in Patients with Primary or Secondary Lung Tumors

    Not yet recruiting

    3 1 1
    Investigated drugs:
    France

  • Study of gallium-68 FAPI imaging to assess blood vessel changes in patients with pulmonary arterial hypertension receiving sotatercept

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Lung Function After Pulmonary Embolism Using Galligas and 68Ga-MAA in Patients with Pulmonary Embolism

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Safety and Effectiveness of 166Holmium Radiation Therapy with Atezolizumab and Bevacizumab for Patients with Non-Resectable Liver Cancer

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France

Glossary

  • Hepatocellular carcinoma (HCC): A type of liver cancer that begins in the main cell type of the liver (hepatocytes).
  • Non-resectable: Referring to a tumor that cannot be surgically removed, often due to its size, location, or spread.
  • SIRT (Selective Internal Radiation Therapy): A targeted radiation treatment that delivers tiny radioactive beads directly to liver tumors through the bloodstream.
  • Atezolizumab: A type of immunotherapy drug that helps the immune system fight cancer cells.
  • Bevacizumab: A targeted therapy drug that works by blocking the growth of new blood vessels that feed tumors.
  • Human Albumin As Macroaggregates: A substance used in medical imaging to help visualize blood flow in organs like the lungs or liver.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Adverse Events (AEs): Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-166holmium-radiation-therapy-with-atezolizumab-and-bevacizumab-for-patients-with-non-resectable-liver-cancer/