Technetium 99m labelled macroaggregated albumin administered during selective arterial embolization of renal angiomyolipoma: a biodistribution study
Phase 2
Completed
- Conditions
- angiomyolipomabenign kidneytumour10038363
- Registration Number
- NL-OMON36687
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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 < 200 µmol/L.
8. Contrast enhancement of AML on CT.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine whether any shunting of Tc-99m-MAA to the lungs occurs.<br /><br>Quantification of lung shunting will be performed using ROI analysis. </p><br>
- Secondary Outcome Measures
Name Time Method <p>- To evaluate shunting of Tc-99m-MAA to the lungs by quantitative SPECT.<br /><br>- To evaluate safety and toxicity.<br /><br>- To evaluate the biodistribution of Tc-99m-MAA in the kidney</p><br>