Diffusion Study on Patients With Osteosarcoma

Osteosarcoma Clinical Trial

Official title:

Monitoring the Response of Osteosarcoma Under Neoadjuvant Chemotherapy: The Value of Dynamic Contrast Enhancement and Diffusion-weighted MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615640
• Other study ID #: 02.08.2010 V.1.0
• Status: Completed
• Start date: September 2010
• Est. completion date: June 7, 2019

Study information

• Verified date: August 2019
• Source: Klinikum Stuttgart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma

Locations

Country	Name	City	State
Germany	Klinikum Stuttgart	Stuttgart	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Stuttgart	University Hospital Freiburg

Country where clinical trial is conducted

Germany,