Healthy, no Evidence of DiseaseNCT01259076
Effect of Weight Loss on Breast Density Using Digital Mammography and MRI in Women Who Are At Increased Risk For Breast Cancer
An observational study of Healthy, no Evidence of Disease, run by Northwestern University at 1 site in United States.
Trial summary
Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss affects breast density in women who are at increased risk for breast cancer. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, no Evidence of Disease
- What is being tested?
- magnetic resonance imaging, digital mammography and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jul 2014
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pre-menopausal women between the ages of 30 and 50 who are eligible and undergoing evaluation for gastric bypass surgery
Who may be able to join
- Women eligible for gastric bypass surgery
- Pre-menopausal women
- All women will have signed an informed consent form prior to participating in study procedures
Who cannot join
- Women with a history of breast cancer
- Women currently taking exogenous hormone replacement therapy
- Women currently taking a SERM
- Women currently taking an aromatase inhibitor
- Pregnant or lactating women
- Women who have been pregnant or lactating in the past 2 years
Show all 12Show fewer
- Women who have metallic or other surgical implants
- All subjects will have a determination of their estimated glomerular filtration rate (eGFR) within 24 hours of undergoing any study where gadolinium based contrast agents will be administered
- Subjects should not have a known history of recent onset acute renal dysfunction
- Subjects with a history of stable chronic renal dysfunction may participate in studies using GBCA based on their eGFR, as outlined below
- Subjects should not have severe liver dysfunction, particularly when associated with kidney disease
- Subjects should receive GBCAs in the perioperative period (i.e. within 4 weeks) after renal or liver transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Weight Loss on Breast Density Using Both Digital Mammography and Breast MRI
Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss affects breast density in women who are at increased risk for breast cancer.
Read the detailed description
OBJECTIVES: I. To determine if weight loss in patients undergoing Roux en Y gastric bypass procedures has any effect on breast density as measured by mammography and breast MRI. OUTLINE: GROUP I: Participants undergo mammography and MRI at baseline and 1 year. Participants also undergo gastric bypass surgery. GROUP II: Participants undergo mammography and MRI at baseline and 1 year. After completion of study treatment, patients are followed up at 1 year.
- Conditions
- Healthy, no Evidence of Disease
- Being tested
- magnetic resonance imaging, digital mammography, conventional surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo MRI at baseline and 1 year later.
digital mammographyProcedure or surgery
Undergo digital mammography at baseline and 1 year later.
conventional surgeryProcedure or surgery
Also called surgery, conventional
Undergo gastric bypass surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants who are eligible for and have opted to undergo gastric bypass surgery Receives: Procedure: magnetic resonance imaging; Procedure: digital mammography; Procedure: conventional surgery | |
| Group 2 | Participants who are eligible for but decided not to undergo gastric bypass surgery. Receives: Procedure: magnetic resonance imaging; Procedure: digital mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI and breast density
Measured: At baseline and year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Study was closed early due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert H. Lurie Cancer Center
- Responsible party
- Sponsor
- Investigators
- Nora Hansen, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259076
- Sponsor's protocol ID
- NU 10B01
- Other IDs
- STU00038177
- Status last verified
- Apr 2015
- First submitted
- 10 Dec 2010
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weight Loss on Breast Density Using Both Digital Mammography and Breast MRI
- ClinicalTrials.gov ID
- NCT01259076
- Acronym / sponsor ID
- NU 10B01
- Conditions
- Healthy, no Evidence of Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was closed early due to slow accrual.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Robert H. Lurie Cancer Center
- Study start
- Feb 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Dec 2010 (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.
Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss affects breast density in women who are at increased risk for breast cancer.
Detailed description
OBJECTIVES: I. To determine if weight loss in patients undergoing Roux en Y gastric bypass procedures has any effect on breast density as measured by mammography and breast MRI. OUTLINE: GROUP I: Participants undergo mammography and MRI at baseline and 1 year. Participants also undergo gastric bypass surgery. GROUP II: Participants undergo mammography and MRI at baseline and 1 year. After completion of study treatment, patients are followed up at 1 year.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: magnetic resonance imaging, Procedure: digital mammography, Procedure: conventional surgeryParticipants who are eligible for and have opted to undergo gastric bypass surgery |
| Group 2 | – | Procedure: magnetic resonance imaging, Procedure: digital mammographyParticipants who are eligible for but decided not to undergo gastric bypass surgery. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pre-menopausal women between the ages of 30 and 50 who are eligible and undergoing evaluation for gastric bypass surgery
Key inclusion criteria (3 listed)
- Women eligible for gastric bypass surgery
- Pre-menopausal women
- All women will have signed an informed consent form prior to participating in study procedures
Key exclusion criteria (12 listed)
- Women with a history of breast cancer
- Women currently taking exogenous hormone replacement therapy
- Women currently taking a SERM
- Women currently taking an aromatase inhibitor
- Pregnant or lactating women
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 |
|---|---|---|
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo MRI at baseline and 1 year later. | Procedure or surgery | Group 1, Group 2 |
| digital mammographyUndergo digital mammography at baseline and 1 year later. | Procedure or surgery | Group 1, Group 2 |
| conventional surgeryAlso: surgery, conventionalUndergo gastric bypass surgery | Procedure or surgery | Group 1 |
Primary outcome
Change in BMI and breast density
Time frame: At baseline and year 1
Results and safety
The study was stopped early (reason given: Study was closed early due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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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.
Nora Hansen principal investigator
Northwestern University
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 Healthy, no Evidence of Disease, run by Northwestern University at 1 site in United States.
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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Apr 2015. 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 United States. 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 stopped early (reason given: Study was closed early due to slow accrual.). Results are not available in the source record.
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?
Change in BMI and breast density (time frame: At baseline and year 1). 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 10 Apr 2015.