Advanced MR Imaging in Sarcoma Patients
A Pilot Study of the Utility of Perfusion MRI and MR Elastography for Surgical Planning, Radiotherapy Target Delineation, and Treatment Response Evaluation in Newly Diagnosed Ewing Sarcoma, Rhabdomyosarcoma and Soft Tissue Sarcoma Patients
We intend to investigate the clinical application of two emerging imaging modalities for which the technical capability is currently in place at Mayo Clinic. The treatment of Ewing Sarcoma (ES), Rhabdomyosarcoma (RMS) and soft tissue sarcoma (STS) patients on this study will involve multi-disciplinary contributions from nationally recognized sarcoma experts in Radiation Oncology, Radiology, Orthopedic Surgery, Pediatric Oncology, Medical Oncology and Pathology.
Patients will undergo additional magnetic resonance (MR) imaging at the same time as the standard imaging.
The ability to compare several imaging modalities within a single cohort of patients maximizes the potential of the study to impact the future management of sarcoma patients. The collaborative nature of this study, with essential contributions from many departments will undoubtedly improve the coordinated care of sarcoma patients and naturally disseminate the advanced imaging experience that is acquired.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
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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:
- Age ≥ 7 years.
- Histological confirmation of newly diagnosed localized or newly diagnosed with metastatic Ewing Sarcoma, Rhabdomyosarcoma or Soft tissue Sarcoma.
- Tumors > 5 cm in diameter.
- Planning to receive RT or surgery with or without adjuvant radiotherapy (RT) at Mayo Clinic Rochester.
- Provide informed written consent if ≥ 18 years. If < 18 years, provide informed written assent and parent or legal guardian provide informed written consent.
- Patients must have measurable disease as defined in Section 11.0.
- Willingness to participate in mandatory imaging studies at Mayo Clinic Rochester.
- Baseline MRE information deemed as acceptable for assessment
- Baseline perfusion MRI deemed as acceptable for assessment
Exclusion Criteria:
- Co-morbid conditions that would result in expected survival to be less than 5 years
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas uniquement
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Establish correlation between perfusion Magnetic Resonance imaging (MRI), 18F-flourodeoxyglucose (18F-FDG) PET activity, MRI contrast enhancement, Magnetic Resonance Elastography (MRE)
Délai: 5 years
|
5 years
|
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Establish correlation between pathologic response for ES, RMS and STS
Délai: 5 years
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5 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Establish a correlation between change in perfusion and tissue stiffness with event-free survival.
Délai: 5 years
|
5 years
|
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Establish a correlation between change in perfusion and tissue stiffness with overall survival.
Délai: 5 years
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5 years
|
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Establish a correlation between change in perfusion and tissue stiffness with local control.
Délai: 5 years
|
5 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Deanna Pafundi, Ph D, Mayo Clinic
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
- 15-005622
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