- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01466426
The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders (The PETVET Study) (PETVET)
The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Acute DVT and PE are common and serious conditions. Highly effective treatment (most often anticoagulant agents) is available for acute VTE, but it is associated with potentially dangerous side effects. In addition, DVT and PE are just two manifestations of VTE, which can occur everywhere in the human organism. An underlying disease (i.e. cancer) is often a key factor in developing VTE.
Commonly used diagnostic imaging techniques in DVT and PE have a fair diagnostic accuracy, but do not address other important aspects of the disease. In contrast to this, FDG-PET/CT has the potential to contribute in VTE diagnosis by
- Differentiate between acute and chronic VTE
- Screening of the entire body for VTE (e.g. the pelvis where normal imaging techniques fail)
- Early diagnosis of underlying disease (e.g. cancer, with the possibility of early treatment)
This is a pilot study with the above mentioned objectives, and is part of a larger study addressing other aspects of FDG-PET/CT in VTE.
The investigators believe that their hypothesis that FDG-PET/CT imaging may introduce a new approach for detecting thrombi anywhere in the body, particularly in the venous system including the pelvis and the calves, will add a new dimension in treating patients with suspected PE. This technology will only detect acute thrombi and not chronic thrombi that no longer have activity, which will obviate unnecessary treatment in this population.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Odense, Danemark, dk-5000
- Dept. of Acute Medicine, Odense University Hospital
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Odense, Danemark, dk-5000
- Dept. of Nuclear Medicine, Odense University Hospital
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Odense, Danemark, dk-5000
- Dept. of Respiratory Medicine, Odense University Hospital,
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Positive or negative diagnosis of VTE (DVT/PE)
- Age ≥ 50 years
- Informed consent obtained
- Symptoms < 1 week
Exclusion Criteria:
- Pregnant or lactating women
- Foreign language patients with a need for an interpreter
- Previous DVT or PE
- Known malignancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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DVT confirmed
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DVT ruled out
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PE confirmed
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PE ruled out
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proof-of-concept
Délai: During diagnostic workup
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Simple assessment of scans - positive or negative in the relevant patient categories
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During diagnostic workup
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Soeren Hess, MD, Odense University Hospital
- Chaise d'étude: Poul Henning Madsen, MD, Odense University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NMA projekt K 59 PETVET
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