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Analysis of liver values after intra-arterial administration of 99mTechnetium-labeled albumin particles before selective internal radiotherapy of the liver and evaluation of these values for the prediction of toxicity.

Analysis of liver values after intra-arterial administration of 99mTechnetium-labeled albumin particles before selective internal radiotherapy of the liver and evaluation of these values for the prediction of toxicity. - TC99mMAA pre RE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025695
Enrollment
202
Registered
2023-02-14
Start date
2021-08-10
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C78.5 C75.9

Interventions

Group 1: The retrospectively studied patients treated by SIRT at the Department of Radiology and Nuclear Medicine at Magdeburg University Hospital received the examinations and therapies according to

Sponsors

Universitätsklinikum Magdeburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 83 Years

Inclusion criteria

Inclusion criteria: - Patients with hepatocellular carcinoma and cholangiocellular carcinoma - Patients with hepatic metastatic carcinoma - Patients who were evaluated by 99mTc-MAA administration and subsequently received SIRT (sequential unilobar, single-stage bilobar (whole liver treatment), or single-stage unilobar) - Determination of liver function parameters (bilirubin, ALAT, ASAT, GLDH) at the following time points: Before 99mTc-MAA administration, 1-3 days after 99mTc-MAA administration, before SIRT (2-4 weeks after 99mTc-MAA administration) and 4-8 weeks after SIRT.

Exclusion criteria

Exclusion criteria: - Participation in the so-called EXPLOSIVE study - Incomplete recording of liver function parameters or patient data. - The sole absence of liver function parameters 4-8 weeks after SIRT is not an exclusion criterion, as this alone concerns the secondary endpoint.

Design outcomes

Primary

MeasureTime frame
Analysis of liver-specific laboratory parameters before and after intra-arterial application of technetium-99-labeled albumin particles with regard to the occurrence of significant laboratory value changes in preparation for SIRT.

Secondary

MeasureTime frame
Secondary endpoint is to investigate whether a relevant change in liver-specific laboratory parameters has predictive value for the development of postradioembolic hepatotoxicity in terms of REILD (Radioembolization Induced Liver Disease).

Countries

Germany

Contacts

Public ContactMax Seidensticker

Klinik und Poliklinik für Radiologie LMU Klinikum der Universität München

Max.Seidensticker@med.uni-muenchen.de089/4400-76642

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026