To assess the occurrence of lung shunting and to evaluate the biodistribution and safety of Technetium 99m labelled macroaggregated albumin (Tc-99m-MAA) after administration to the kidney.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine whether any shunting of Tc-99m-MAA to the lungs occurs.
Quantification of lung shunting will be performed using ROI analysis.
Secondary outcome
- 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
Background summary
A need to further improve the intra arterial treatment of renal angiomyolipoma
is recognized, since current treatment options often require multiple
interventions due to tumor recurrences. Intra-arterial local delivery of a
therapeutic agent may lead to an overall improvement of the treatment regimen.
Study objective
To assess the occurrence of lung shunting and to evaluate the biodistribution
and safety of Technetium 99m labelled macroaggregated albumin (Tc-99m-MAA)
after administration to the kidney.
Study design
non-randomised, open label, uncontrolled pilot study.
Intervention
Prior to the selective arterial embolisation a dose of 150 MBq Tc-99m-MAA will
be administered into the angiomyolipoma via catheter.
Study burden and risks
Patients included in this study are scheduled for a selective arterial
embolization procedure. In this procedure patients will receive a 150 MBq dose
of Tc-99m-MAA which corresponds to approximately 1,6mSv. Tc-99m-MAA has proven
to be safe and is used frequently for diagnostic purposes. A systemic allergic
reaction can occur, consisting of erythema of the skin, itching and dyspnea.
Standard protocol prescribes that after the embolization procedure the patient
has to rest for approximately four hours. During this time SPECT will be
performed in order to determine the biodistribution. For this the patient has
to lie on an examination table for one hour. Participation in this study may
possibly produce useful scientific data for the future.
Heidelberglaan 100
3584 CX UTRECHT
NL
Heidelberglaan 100
3584 CX UTRECHT
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-022275-60-NL |
| CCMO | NL32409.041.10 |