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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01615640
Other study ID # 02.08.2010 V.1.0
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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, 

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