Diffusion Study on Patients With Osteosarcoma

NCT ID: NCT01615640

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2019-06-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteosarcoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Osteosarcoma patients

Patients with an histologically proven osteosarcoma will be entered into the study.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Freiburg

OTHER

Sponsor Role collaborator

Klinikum Stuttgart

OTHER

Sponsor Role lead

Responsible Party

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Dr. Thekla von Kalle

Dr. Thekla von Kalle

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thekla von Kalle, Doctor

Role: PRINCIPAL_INVESTIGATOR

Klinikum Stuttgart

Locations

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Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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02.08.2010 V.1.0

Identifier Type: -

Identifier Source: org_study_id

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