Breast DiseasesNCT01749748
The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
A study testing proton magnetic resonance spectroscopy in people with Breast Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To delineate if the chemical composition (lipid and water) in the presumably normal breast of the high risk women is different from those of the low risk group. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Diseases
- What is being tested?
- proton magnetic resonance spectroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to Feb 2016
- Phase
- Interventional
- 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 25 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women without breast symptoms (without family history of breast cancer; or with at least first-degree relative of breast cancer) with negative mammography and ultrasound result in recent 3 months or contralateral normal breasts from women with newly diagnosed unilateral breast cancer
- 25-75 years old.
Who cannot join
- renal function impairment
- past history of anaphylactoid reaction to MRI contrast media (Gd-DTPA)
- pregnant or lactating women
- medication of HRT or oral pills in recent 6 months
- past history of surgery of the breast (either side)
- past history of breast cancer
- with breast implant or silicone injection
- past history of cardiac surgery, mechanical valve replacement, aneurismal clip, endotracheal tube or tracheostomy tube, any metallic implants.
Trial locations and contacts
1 site in 1 country.
About this study
To delineate if the chemical composition (lipid and water) in the presumably normal breast of the high risk women is different from those of the low risk group.
Read the detailed description
The researchers would like to investigate and compare the chemical composition in the normal breast between high risk women and general population.
- Conditions
- Breast Diseases
- Being tested
- proton magnetic resonance spectroscopy
- Keywords
- Breast diseases, magnetic resonance spectroscopy
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton magnetic resonance spectroscopyProcedure or surgery
Also called proton MRS
proton magnetic resonance spectroscopy was performed for the normal breast to evaluate the chemical composition of breast
| Study group | Role | What they receive |
|---|---|---|
| proton magnetic resonance spectroscopy | Other | proton magnetic resonance spectroscopy for asymptomatic women breasts. Receives: Procedure: proton magnetic resonance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of lipid water composition and ratio of the normal breasts in women of high risk group and low risk group.
This is a cross sectional study. And we just assess the chemical composition of normal breasts of women at a given time point, since the participants only received one time of study.
Measured: up to 5 years ( July 2008 to June 2013)
Secondary outcomes (2)
to investigate the association between breast density and lipid water ratio of normal breasts
to investigate whether there is association of breast density and chemical composition of normal breast on proton magnetic resonance spectroscopy.
Measured: up to 5 years (July 2008 to June 2013)
to investigate the association between menopausal status and lipid water ratio of normal breasts
to investigate whether there is association of menopausal status and chemical composition of normal breast on proton magnetic resonance spectroscopy.
Measured: up to 5 years ( July 2008 to June 2013)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJul 2008
- Primary completionAug 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Jane Wang, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749748
- Sponsor's protocol ID
- 200806009R
- Status last verified
- Feb 2016
- First submitted
- 17 Nov 2012
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Breast MRI Screening and Proton Magnetic Resonance Spectroscopy
- ClinicalTrials.gov ID
- NCT01749748
- Acronym / sponsor ID
- 200806009R
- Conditions
- Breast Diseases
- Keywords
- Breast diseases, magnetic resonance spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Dec 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.
To delineate if the chemical composition (lipid and water) in the presumably normal breast of the high risk women is different from those of the low risk group.
Detailed description
The researchers would like to investigate and compare the chemical composition in the normal breast between high risk women and general population.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proton magnetic resonance spectroscopy | Other | Procedure: proton magnetic resonance spectroscopyproton magnetic resonance spectroscopy for asymptomatic women breasts. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women without breast symptoms (without family history of breast cancer; or with at least first-degree relative of breast cancer) with negative mammography and ultrasound result in recent 3 months or contralateral normal breasts from women with newly diagnosed unilateral breast cancer
- 25-75 years old.
Key exclusion criteria (8 listed)
- renal function impairment
- past history of anaphylactoid reaction to MRI contrast media (Gd-DTPA)
- pregnant or lactating women
- medication of HRT or oral pills in recent 6 months
- past history of surgery of the breast (either side)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proton magnetic resonance spectroscopyAlso: proton MRSproton magnetic resonance spectroscopy was performed for the normal breast to evaluate the chemical composition of breast | Procedure or surgery | proton magnetic resonance spectroscopy |
Primary outcome
comparison of lipid water composition and ratio of the normal breasts in women of high risk group and low risk group.
Time frame: up to 5 years ( July 2008 to June 2013)
This is a cross sectional study. And we just assess the chemical composition of normal breasts of women at a given time point, since the participants only received one time of study.
2 secondary outcomes
to investigate the association between breast density and lipid water ratio of normal breasts
Time frame: up to 5 years (July 2008 to June 2013)
to investigate the association between menopausal status and lipid water ratio of normal breasts
Time frame: up to 5 years ( July 2008 to June 2013)
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 2 Feb 2016.
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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, PhD 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?
A study testing proton magnetic resonance spectroscopy in people with Breast Diseases, 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 2 inclusion and 8 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 2 Feb 2016. 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?
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.
What does the primary outcome measure?
comparison of lipid water composition and ratio of the normal breasts in women of high risk group and low risk group. (time frame: up to 5 years ( July 2008 to June 2013)). It is what the study was designed to measure, not a finding.
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 Feb 2016.