Breast NeoplasmsNCT00155090
Proton Magnetic Resonance Spectroscopy of Normal Breast Tissues in Women Volunteers
An observational study of Breast Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Magnetic resonance spectroscopy (MRS) is a diagnostic technique in MRI that distinguishes various metabolites on the basis of their slightly different chemical shifts or resonance frequencies. The Proton is the most abundant nucleus in the body. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2005to Dec 2005
- 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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women age ranged 30 years of age or older, with normal mammograms or ultrasound in recent 3 months
Who cannot join
- any women not fulfilling the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jane Wang, MD, 886-2-23123456 ext. 5565, hstjen@yahoo.com.tw
Jane Wang, MD
About this study
Magnetic resonance spectroscopy (MRS) is a diagnostic technique in MRI that distinguishes various metabolites on the basis of their slightly different chemical shifts or resonance frequencies. The Proton is the most abundant nucleus in the body. We will try to establish the typical proton MRS pattern of normal women breasts to be a guideline for future further investigations.
Read the detailed description
There are few reports regarding proton MRS in normal female breasts. The fibroglandular tissues and fat are the two major gross components in the breast. The water content in the fibroglandular tissues is much higher than that in the fat. There is still no documented report discussing proton MRS in normal female breasts of premenopausal and postmenopausal women. Our study is to evaluate the proton MRS findings among normal premenopausal and postmenopausal women breasts, to find out if there are statistical differences on the main proton MRS patterns, water and lipid peak intensities and ratios between the two groups.
- Conditions
- Breast Neoplasms
- Keywords
- Magnetic resonance imaging,, breast disease
- Medical subject headings
- Breast Neoplasms, Breast Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jane Wang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155090
- Sponsor's protocol ID
- 9361700788
- Status last verified
- Jan 2005
- First submitted
- 9 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Publications
Kvistad KA, Bakken IJ, Gribbestad IS, Ehrnholm B, Lundgren S, Fjosne HE, Haraldseth O. Characterization of neoplastic and normal human breast tissues with in vivo (1)H MR spectroscopy. J Magn Reson Imaging. 1999 Aug;10(2):159-64. doi: 10.1002/(sici)1522-2586(199908)10:23.0.co;2-0.
PubMed 10441019
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Magnetic Resonance Spectroscopy of Normal Breast Tissues in Women Volunteers
- ClinicalTrials.gov ID
- NCT00155090
- Acronym / sponsor ID
- 9361700788
- Conditions
- Breast Neoplasms
- Keywords
- Magnetic resonance imaging,, breast disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Dec 2005
- First posted
- 12 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.
Magnetic resonance spectroscopy (MRS) is a diagnostic technique in MRI that distinguishes various metabolites on the basis of their slightly different chemical shifts or resonance frequencies. The Proton is the most abundant nucleus in the body. We will try to establish the typical proton MRS pattern of normal women breasts to be a guideline for future further investigations.
Detailed description
There are few reports regarding proton MRS in normal female breasts. The fibroglandular tissues and fat are the two major gross components in the breast. The water content in the fibroglandular tissues is much higher than that in the fat. There is still no documented report discussing proton MRS in normal female breasts of premenopausal and postmenopausal women. Our study is to evaluate the proton MRS findings among normal premenopausal and postmenopausal women breasts, to find out if there are statistical differences on the main proton MRS patterns, water and lipid peak intensities and ratios between the two groups.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women age ranged 30 years of age or older, with normal mammograms or ultrasound in recent 3 months
Key exclusion criteria (1 listed)
- any women not fulfilling the inclusion criteria
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
- Background: PubMed 10441019Kvistad KA, Bakken IJ, Gribbestad IS, Ehrnholm B, Lundgren S, Fjosne HE, Haraldseth O. Characterization of neoplastic and normal human breast tissues with in vivo (1)H MR spectroscopy. J Magn Reson Imaging. 1999 Aug;10(2):159-64. doi: 10.1002/(sici)1522-2586(199908)10:23.0.co;2-0.
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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.
Jane Wang, MD principal investigator
National Taiwan 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 Breast Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 12 Sep 2005. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Wang, MD (886-2-23123456 ext. 5565, hstjen@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00155090, which also lists 1 linked publication.
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 12 Sep 2005.