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
Recruitment status was Recruiting
Sponsor:
Klinikum Stuttgart
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
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Purpose
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 |
|---|
|
Osteosarcoma |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Bone Cancer
Osteosarcoma
Malignant Mesenchymal Tumor
Soft Tissue Sarcoma
U.S. FDA Resources
Further study details as provided by Klinikum Stuttgart:
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2010 |
| Groups/Cohorts |
|---|
|
Osteosarcoma patients
Patients with an histologically proven osteosarcoma will be entered into the study.
|
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615640
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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 |
| Study First Received: | June 6, 2012 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 23, 2016