Diffusion Study on Patients With Osteosarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Klinikum Stuttgart.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital Freiburg
Information provided by (Responsible Party):
Dr. Thekla von Kalle, Klinikum Stuttgart
ClinicalTrials.gov Identifier:
NCT01615640
First received: June 6, 2012
Last updated: June 7, 2012
Last verified: June 2012

June 6, 2012
June 7, 2012
September 2010
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Complete list of historical versions of study NCT01615640 on ClinicalTrials.gov Archive Site
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Diffusion Study on Patients With Osteosarcoma
Monitoring the Response of Osteosarcoma Under Neoadjuvant Chemotherapy: The Value of Dynamic Contrast Enhancement and Diffusion-weighted MRI

The aim of the study is to assess the accuracy of dynamic contrast enhanced and diffusion-weighted MR Imaging in evaluating response to chemotherapy in osteosarcoma.

Dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging have the potential to measure early cellular and vascular changes that occur in response to chemotherapy and could therefore be early predictors of therapeutic response.

Aim of our study is to assess the accuracy of dynamic contrast enhanced and diffusion-weighted MR imaging in evaluating response to chemotherapy during the preoperative treatment of osteosarcoma. Patients will undergo dynamic contrast-enhanced and diffusion-weighted magnetic resonance imaging before, during and after chemotherapy.

Our long-term goal is to use these imaging techniques to develop non-invasive methodologies that would be better predictors of tumor response than the current clinical standard and earlier predictors than histological evaluation of the whole tumor.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

German, Austrian and Swiss patients with an osteosarcoma will be entered into the study.

Osteosarcoma
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Osteosarcoma patients
Patients with an histologically proven osteosarcoma will be entered into the study.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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Inclusion Criteria:

  • Histologically confirmed diagnosis of osteosarcoma of all entities
  • Written informed consent of patient

Exclusion Criteria:

  • No written informed consent
  • Contraindications to MRI (pacemaker, aneurysm clip, mechanical and/or electrical device or metallic fragment, severe claustrophobia)
  • Severe, active co-morbidity
  • Major medical illnesses or psychiatric impairments
Both
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No
Contact: Thekla von Kalle, Doctor +49 (0) 711/ 278-73303 t.vonkalle@klinikum-stuttgart.de
Germany
 
NCT01615640
02.08.2010 V.1.0
No
Dr. Thekla von Kalle, Klinikum Stuttgart
Klinikum Stuttgart
University Hospital Freiburg
Principal Investigator: Thekla von Kalle, Doctor Klinikum Stuttgart
Klinikum Stuttgart
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP