Ga-68-DOTA-(RGD)2 PET/CT: imaging angiogenesis in patients with arterio-venous malformations

Phase 2

Completed

Conditions: arterio-venous malformation
AVM
10005330

Registration Number: NL-OMON53156

Lead Sponsor: Radiologie en Nucleaire Geneeskunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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

- Contra-indication for PET (Pregnancy; Breast-feeding, or Severe claustrophobia)
- Impaired renal function (Creatinin clearance <= 60 mL/min according to the The Cockcroft-Gault equation
- Impaired liver function (ALAT, ASAT >= 3x ULN; Total bilirubin >= 2x ULN)
- Other serious illness

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the tracer uptake (Ga-68-DOTA-(RGD)2) in the AVM<br /><br>lesion as quantified by PET/CT. The tracer uptake is calculated as the ratio of<br /><br>the tissue radioactivity concentration c (MBq/kg) and the injected activity<br /><br>(MBq), divided by the body weight (kg): SUV=c/(injected activity/weight). SUV<br /><br>data will be presented as mean and standard deviations.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additional study parameter is the lesion-to-background ratio (LBR).<br /><br>Furthermore, safety analysis will be performed, including the recording of<br /><br>adverse events, changes in vital signs (blood pressure, heart rate, and<br /><br>temperature), and blood measurements (ALAT, ASAT, bilirubin, creatinin, ureum,<br /><br>Hb, Ht, leucocytes, and thrombocytes) before, and after administration of<br /><br>Ga-68-DOTA-(RGD)2.</p><br>