Breast NeoplasmsNCT00201487
Choline Quantification in Breast Cancer by MRS
An observational study of Breast Neoplasms, run by Norwegian University of Science and Technology.
Trial summary
Choline has been found in increased concentration in breast cancer patients. Hypothesis: The choline signal as observed by MRS is sensitive to treatment, and a positive response to treatment will give a reduction in choline concentration. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Nov 2007
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: breast cancer
Who may be able to join
- breast cancer
Who cannot join
- -
About this study
Choline has been found in increased concentration in breast cancer patients. Hypothesis: The choline signal as observed by MRS is sensitive to treatment, and a positive response to treatment will give a reduction in choline concentration.
The purpose of this study is to establish methods for quantification of choline in breast cancer by MRS
Read the detailed description
- Establishment of new MRS sequence for choline quantification of choline. This sequence is choline-selective, and signals from water and lipids are suppressed simultaneously.
- Compare to different methods for choline quantification. The first method is quantification through an external phantom standard, containing a known concentration of choline. The other method is based on the utilisation of internal water signal as a reference.
Both calculations can be performed from the same MR exam. Ten patients will be included in the study.
- Conditions
- Breast Neoplasms
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2007
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: We chose to use an exsisting NMR pulse sequence already established and available at the hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Cohort
- 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 Norwegian Women´s Public Health Association
- Responsible party
- Sponsor
- Investigators
- Tone Bathen, PhD, Principal investigator, NTNU, Faculty of medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201487
- Sponsor's protocol ID
- 11870
- Status last verified
- Oct 2013
- First submitted
- 16 Sep 2005
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choline Quantification in Breast Cancer by MRS
- ClinicalTrials.gov ID
- NCT00201487
- Acronym / sponsor ID
- 11870
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: We chose to use an exsisting NMR pulse sequence already established and available at the hospital.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association
- Study start
- Nov 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 20 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.
Choline has been found in increased concentration in breast cancer patients. Hypothesis: The choline signal as observed by MRS is sensitive to treatment, and a positive response to treatment will give a reduction in choline concentration.
The purpose of this study is to establish methods for quantification of choline in breast cancer by MRS
Detailed description
- Establishment of new MRS sequence for choline quantification of choline. This sequence is choline-selective, and signals from water and lipids are suppressed simultaneously.
- Compare to different methods for choline quantification. The first method is quantification through an external phantom standard, containing a known concentration of choline. The other method is based on the utilisation of internal water signal as a reference.
Both calculations can be performed from the same MR exam. Ten patients will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer
Key inclusion criteria (1 listed)
- breast cancer
Key exclusion criteria (1 listed)
- -
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 31 Oct 2013.
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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.
Tone Bathen, PhD principal investigator
NTNU, Faculty of medicine,
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Norwegian University of Science and Technology.
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 1 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 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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 31 Oct 2013.