NCT01615640

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

8.8 years

First QC Date

June 6, 2012

Last Update Submit

August 13, 2019

Conditions

Osteosarcoma

Keywords

OsteosarcomaResponse of chemotherapyDynamic contrast medium examinationDiffusion-weighted MR imaging

Study Arms (1)

Osteosarcoma patients

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

German, Austrian and Swiss patients with an osteosarcoma will be entered into the study.

You may qualify if:

  • Histologically confirmed diagnosis of osteosarcoma of all entities
  • Written informed consent of patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70176, Germany

Location

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Study Officials

  • Thekla von Kalle, Doctor

    Klinikum Stuttgart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Thekla von Kalle

Study Record Dates

First Submitted

June 6, 2012

First Posted

June 8, 2012

Study Start

September 1, 2010

Primary Completion

June 7, 2019

Study Completion

June 7, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

DE(1)