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

Ga-68-DOTA-(RGD)2 PET/CT: imaging angiogenesis in patients with low-flow vascular malformations - Ga-68-DOTA-RGD2 PET/CT in low-flow vascular malformations

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44225
Enrollment
20
Registered
2017-12-07
Start date
2018-10-31
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

low-flow vascular malformation lymphatic malformation venous malformation

Interventions

None listed

Sponsors

Radiologie en Nucleaire Geneeskunde
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: • Contra-indication for PET/CT: Pregnancy, Breast-feeding, Severe claustrophobia;• Impaired renal function: Creatinine clearance = 3x ULN or Total bilirubin >= 2x ULN ;• Other serious illness

Design outcomes

Primary

MeasureTime frame
The main study parameter is the tracer uptake (68Ga-DOTA-(RGD)2) in the low-flow vascular malformation, 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

MeasureTime frame
The additional study parameter is the lesion-to-background ratio (LBR).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)