Neoplasm MetastasisNCT00184288
Proton MR Spectroscopy of Brain Metastases in Evaluation of Treatment Response.
An observational study of Neoplasm Metastasis and Lung Neoplasms, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of the study is to investigate the feasibility of in vivo single volume MR spectroscopy in evaluation of treatment response in patients with brain metastases, using 3T MR instrument. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis, Lung Neoplasms, Breast Neoplasms
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2004to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with brain metastases
Who may be able to join
- Clinical diagnosis of brain metastases
Who cannot join
- children
- pregnancy
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology, Faculty of Medicine
Trondheim, N-7489
About this study
Official title: Single Volume 1H MR Spectroscopy of Brain Metastases in Evaluation of Treatment Response.
The aim of the study is to investigate the feasibility of in vivo single volume MR spectroscopy in evaluation of treatment response in patients with brain metastases, using 3T MR instrument. In order to optimize and avoid ineffective treatment of patients with brain metastases, in vivo MR spectroscopy can be an useful tool.
- Conditions
- Neoplasm Metastasis, Lung Neoplasms, Breast Neoplasms, Melanoma
- Keywords
- Lipid, choline, metastasis, magnetic resonance spectroscopy, treatment response
- Medical subject headings
- Neoplasm Metastasis, Lung Neoplasms, Breast Neoplasms, Melanoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionJun 2006
- Study completionDec 2010
Why it stopped: no patients recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Steinar Lundgren, MD PhD, Study director, Cancer clinic, St.Olavs Hospital Trondheim University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184288
- Sponsor's protocol ID
- 11184
- Status last verified
- Oct 2011
- First submitted
- 13 Sep 2005
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Volume 1H MR Spectroscopy of Brain Metastases in Evaluation of Treatment Response.
- ClinicalTrials.gov ID
- NCT00184288
- Acronym / sponsor ID
- 11184
- Conditions
- Neoplasm Metastasis, Lung Neoplasms, Breast Neoplasms, Melanoma
- Keywords
- Lipid, choline, metastasis, magnetic resonance spectroscopy, treatment response
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no patients recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Royal Norwegian Ministry of Health
- Study start
- Nov 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Sep 2005 (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 investigate the feasibility of in vivo single volume MR spectroscopy in evaluation of treatment response in patients with brain metastases, using 3T MR instrument. In order to optimize and avoid ineffective treatment of patients with brain metastases, in vivo MR spectroscopy can be an useful tool.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with brain metastases
Key inclusion criteria (1 listed)
- Clinical diagnosis of brain metastases
Key exclusion criteria (2 listed)
- children
- pregnancy
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
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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.
Steinar Lundgren, MD PhD study director
Cancer clinic, St.Olavs Hospital Trondheim University Hospital
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 Neoplasm Metastasis and Lung Neoplasms, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 2 Nov 2011. 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 Norway. 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 was withdrawn before enrolling participants, so there are no results.
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 2 Nov 2011.