arterio-venous malformation AVM
Conditions
Interventions
alpha-v-beta-3 integrin
Arterio-venous malformations
Feasibility study
PET imaging
Sponsors
Radiologie en Nucleaire Geneeskunde
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patients with AVM, with at least one lesion with a diameter of at least 1.5 cm as measured with a diagnostic modality (CT or MRI) and planned for therapeutic intervention; - More than or equal to 18 years of age; - Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: - Contra-indication for PET (Pregnancy; Breast-feeding, or Severe claustrophobia) - Impaired renal function (Creatinin clearance = 3x ULN; Total bilirubin >= 2x ULN) - Other serious illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the tracer uptake (Ga-68-DOTA-(RGD)2) in the AVM lesion as quantified by PET/CT. The tracer uptake is calculated as the ratio of the tissue radioactivity concentration c (MBq/kg) and the injected activity (MBq), divided by the body weight (kg): SUV=c/(injected activity/weight). SUV data will be presented as mean and standard deviations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional study parameter is the lesion-to-background ratio (LBR). Furthermore, safety analysis will be performed, including the recording of adverse events, changes in vital signs (blood pressure, heart rate, and temperature), and blood measurements (ALAT, ASAT, bilirubin, creatinin, ureum, Hb, Ht, leucocytes, and thrombocytes) before, and after administration of Ga-68-DOTA-(RGD)2. | — |
Countries
The Netherlands
Outcome results
None listed