Ga-68-DOTA-(RGD)2 PET/CT: imaging angiogenesis in patients with low-flow vascular malformations

Phase 2

Recruiting

• Conditions: low-flow vascular malformation; lymphatic malformation; venous malformation; 10007510

• Registration Number: NL-OMON44225
• Lead Sponsor: Radiologie en Nucleaire Geneeskunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Patients with a low-flow vascular malformation, who are scheduled for embolization therapy;- More than or equal to 18 years of age;- Ability to provide written informed consent

Exclusion Criteria

• Contra-indication for PET/CT: Pregnancy, Breast-feeding, Severe claustrophobia;• Impaired renal function: Creatinine clearance <= 60 mL/min according to The Cockcroft-Gault equation;• Impaired liver function: ALAT, ASAT >= 3x ULN or 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 (68Ga-DOTA-(RGD)2) in the<br /><br>low-flow vascular malformation, as quantified by PET/CT. The tracer uptake is<br /><br>calculated as the ratio of the tissue radioactivity concentration c (MBq/kg)<br /><br>and the injected activity (MBq), divided by the body weight (kg):<br /><br>SUV=c/(injected activity/weight). SUV data will be presented as mean and<br /><br>standard deviations. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The additional study parameter is the lesion-to-background ratio (LBR). </p><br>