SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA (MAApping)

Sirtex Medical

Status and phase: Completed; Phase 4

Conditions: Carcinoma, Hepatocellular; Liver Neoplasm; Carcinoma

Treatments: Drug: 99mTc-Macro Albumin Aggregate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05848947

STX2301

Details and patient eligibility

About

The goal of this interventional clinical trial is to evaluate the dose of radiation of Technetium-99m macroaggregated-albumin (99mTc-MAA) after an intra-arterial injection to the whole body and non-liver critical organs in patients who are undergoing evaluation for SIR-Spheres treatment for hepatocellular carcinoma.

Full description

The investigation is a prospective, single center, open label, single-arm study. Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA injection, the final of which will occur between 18 and 24 hours post-injection.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Willing, able, and mentally competent to provide written informed consent
2. Age 18 or older at the time of consent
3. Patients who are being evaluated for SIR-Spheres treatment eligibility

Exclusion criteria

1. Patients who are contraindicated for SIR-Spheres treatment
2. Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

99mTc-MAA Injection

Other group

Description:

Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA Injection with the final scan occurring 18-24 hours after injection.

Treatment:

Drug: 99mTc-Macro Albumin Aggregate