Diffusion Study on Patients With Osteosarcoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified June 2012 by Dr. Thekla von Kalle, Klinikum Stuttgart.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01615640

First Posted: June 8, 2012

Last Update Posted: June 8, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

University Hospital Freiburg

Information provided by (Responsible Party):

Dr. Thekla von Kalle, Klinikum Stuttgart

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: Osteosarcoma Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Dr. Thekla von Kalle, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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


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 Submitted:	June 6, 2012
First Posted:	June 8, 2012
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

To Top