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
  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:


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

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

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

No publications provided

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 July 31, 2014