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Diffusion Study on Patients With Osteosarcoma

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ClinicalTrials.gov Identifier: NCT01615640
Recruitment Status : Unknown
Verified June 2012 by Dr. Thekla von Kalle, Klinikum Stuttgart.
Recruitment status was:  Recruiting
First Posted : June 8, 2012
Last Update Posted : June 8, 2012
Sponsor:
Collaborator:
University Hospital Freiburg
Information provided by (Responsible Party):
Dr. Thekla von Kalle, Klinikum Stuttgart

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Osteosarcoma

Detailed Description:

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.


Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring the Response of Osteosarcoma Under Neoadjuvant Chemotherapy: The Value of Dynamic Contrast Enhancement and Diffusion-weighted MRI
Study Start Date : September 2010

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U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Osteosarcoma patients
Patients with an histologically proven osteosarcoma will be entered into the study.


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
German, Austrian and Swiss patients with an osteosarcoma will be entered into the study.
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615640


Contacts
Contact: Thekla von Kalle, Doctor +49 (0) 711/ 278-73303 t.vonkalle@klinikum-stuttgart.de

Locations
Germany
Klinikum Stuttgart Recruiting
Stuttgart, Baden-Württemberg, Germany, 70176
Sponsors and Collaborators
Klinikum Stuttgart
University Hospital Freiburg
Investigators
Principal Investigator: Thekla von Kalle, Doctor Klinikum Stuttgart
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr. Thekla von Kalle, Klinikum Stuttgart
ClinicalTrials.gov Identifier: NCT01615640     History of Changes
Other Study ID Numbers: 02.08.2010 V.1.0
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: June 8, 2012
Last Verified: June 2012

Keywords provided by Dr. Thekla von Kalle, Klinikum Stuttgart:
Osteosarcoma
Response of chemotherapy
Dynamic contrast medium examination
Diffusion-weighted MR imaging

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma