Technetium 99m labelled macroaggregated albumin administered during selective arterial embolization of renal angiomyolipoma: a biodistribution study

Technetium 99m labelled macroaggregated albumin administered during selective arterial embolization of renal angiomyolipoma: a biodistribution study - iRENAL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36687

Enrollment

Registered

2010-10-01

Start date

2012-01-23

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

angiomyolipoma benign kidneytumour

Interventions

Prior to the selective arterial embolisation a dose of 150 MBq Tc-99m-MAA will be administered into the angiomyolipoma via catheter.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients must have given written informed consent. 2. Female or male aged 18 years and over. 3. Confirmed diagnosis of AML defined by CT. 4. Clinical indication for selective arterial embolization. 5. World Health Organisation Performance status 0-2. 6. One or more lesions of at least 4 cm in the longest diameter by spiral CT. 7. Serum creatinine

Exclusion criteria

Exclusion criteria: 1. Patients who are mentally disabled. 2. Pregnancy or breast feeding. 3. Patients with a significant right to left cardiac shunt. 4. Patients with pulmonary hypertension.

Design outcomes

Primary

Measure	Time frame
To determine whether any shunting of Tc-99m-MAA to the lungs occurs. Quantification of lung shunting will be performed using ROI analysis.	—

Secondary

Measure	Time frame
- To evaluate shunting of Tc-99m-MAA to the lungs by quantitative SPECT. - To evaluate safety and toxicity. - To evaluate the biodistribution of Tc-99m-MAA in the kidney	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)