OsteosarcomaNCT01615640
Diffusion Study on Patients With Osteosarcoma
An observational study of Osteosarcoma, run by Klinikum Stuttgart at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteosarcoma
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to 7 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: German, Austrian and Swiss patients with an osteosarcoma will be entered into the study.
Who may be able to join
- Histologically confirmed diagnosis of osteosarcoma of all entities
- Written informed consent of patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring the Response of Osteosarcoma Under Neoadjuvant Chemotherapy: The Value of Dynamic Contrast Enhancement and Diffusion-weighted MRI
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.
Read the 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.
- Conditions
- Osteosarcoma
- Keywords
- Osteosarcoma, Response of chemotherapy, Dynamic contrast medium examination, Diffusion-weighted MR imaging
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Osteosarcoma patients | Patients with an histologically proven osteosarcoma will be entered into the study. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startSep 2010
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Stuttgart
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Freiburg
- Responsible party
- Principal investigator, Dr. Thekla von Kalle, Klinikum Stuttgart
- Investigators
- Thekla von Kalle, Doctor, Principal investigator, Klinikum Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615640
- Sponsor's protocol ID
- 02.08.2010 V.1.0
- Status last verified
- Aug 2019
- First submitted
- 6 Jun 2012
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Response of Osteosarcoma Under Neoadjuvant Chemotherapy: The Value of Dynamic Contrast Enhancement and Diffusion-weighted MRI
- ClinicalTrials.gov ID
- NCT01615640
- Acronym / sponsor ID
- 02.08.2010 V.1.0
- Conditions
- Osteosarcoma
- Keywords
- Osteosarcoma, Response of chemotherapy, Dynamic contrast medium examination, Diffusion-weighted MR imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Klinikum StuttgartUniversity, hospital or other
- Collaborators
- University Hospital Freiburg
- Study start
- Sep 2010 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteosarcoma patients | – | –Patients with an histologically proven osteosarcoma will be entered into the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- German, Austrian and Swiss patients with an osteosarcoma will be entered into the study.
Key inclusion criteria (2 listed)
- Histologically confirmed diagnosis of osteosarcoma of all entities
- Written informed consent of patient
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thekla von Kalle, Doctor principal investigator
Klinikum Stuttgart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma, run by Klinikum Stuttgart at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.