Radioactive holmium microspheres for the treatment of patients with non-resectable liver metastases of mixed origin; a single center, interventional, non-randomized, open label, safety study.

Radioactive holmium microspheres for the treatment of patients with non-resectable liver metastases of mixed origin; a single center, interventional, non-randomized, open label, safety study. - HEPAR-trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35649

Enrollment

Registered

2009-08-04

Start date

2009-11-30

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver metastases of mixed origines

Interventions

Ho-166-PLLA-MS will be administered via a catheter (type Cobra glide-catheter (Cook) 5 French) during angiography.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients must have given written informed consent. - Female or male aged 18 years and over. - Confirmed histological diagnosis of metastatic malignancy with dominant liver metastases without standard therapeutic options for treatment including chemotherapy or surgery. - Life expectancy of 12 weeks or longer. - World Health Organisation (WHO) Performance status 0-2. - One or more measurable lesions at least 10 mm in the longest diameter by spiral Computed Tomography (CT) scan. - Negative pregnancy test for women of childbearing potential.

Exclusion criteria

Exclusion criteria: - Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week. - Radiation therapy or the last dose of prior chemotherapie within the last 4 weeks before the start of study therapy. - Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy. - Serum bilirubin > 1.5 x Upper Limit of Normal (ULN). - Serum creatinine > 185 µmol/L. - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN. - Leukocytes 3 kg. - Patients who have arterial variations that will not allow whole liver treatment by a single administration via the hepatic artery

Design outcomes

Primary

Measure	Time frame
Safety and toxicity profile of treatment with Ho-166-PLLA-MS.	—

Secondary

Measure	Time frame
• Tumor response. • Patient dosimetry. • Performance status. • Quality of Life. • Comparison of Tc-MAA-scan and Ho-166-PLLA-MS safety dose scan.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)