- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00676455
Computer Assisted Volumetric Analysis of CT-Identified Metastatic Pulmonary Or Hepatic Lesions
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This is a Pilot Study that will evaluate if metastatic liver and lung tumor measurements made by the MeVis™ software program can provide more accurate information about the size and changes of the tumor compared to the current evaluation method, RECIST(Response Evaluation In Solid Tumors). This study will also collect information about the kind of treatment each subject receives.
Subjects will receive standard of care surveillance CT examinations(a baseline to document tumor size and interval CT exams as indicated by the Oncology Department Protocols); the tumor will be measured according to the current standard-RECIST by Radiology personnel not involved in the study. The CT data will then be analyzed by investigators using the MeVis™ software.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
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Massachusetts
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Burlington, Massachusetts, États-Unis, 01805
- Lahey Clinic, Inc.
-
-
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:
- Subjects with cancer metastatic to either the liver or lungs
- Subjects Scheduled for regular CT surveillance examinations
- Subjects with life expectancy of at least 6 months
Exclusion Criteria:
- Age <18 years
- No written informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
This Study Assessed the Ability of MeVis™ Volumetry Software to Reproducibly Measure the Changes in Metastatic Hepatic and Pulmonary Lesions
Délai: As long as treatment is being assessed by CT examinations
|
Due to the low enrollment for this project the data collected is not sufficient to provide any significant conclusion to the primary outcome hypothesis. Due to lack of participants. No significant findings are reported at this time. |
As long as treatment is being assessed by CT examinations
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Tumor Size Will be Measured by CT (by the MeVis Volumetry Software and Correlated With On-going Treatment Plan.
Délai: As long as treatment is being assessed by CT examinations
|
Tumor size will be measured by CT (by the MeVis Volumetry Software and correlated with on-going treatment plan. Correlation of the tumor growth with clinical treatment will be assessed. Tumor size will be expressed in volume. Specifically Three dimensional volume Volume of Interest(VOI)will be calculated and correlated with the treatment protocol. Measure = tumor volume. |
As long as treatment is being assessed by CT examinations
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Christoph Wald, M.D., Ph.D, Lahey Clinic, Inc.
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
- 2007-017
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