Clinical trial · Observational
Effect of Weight Loss on Breast Density Using Digital Mammography and MRI in Women Who Are At Increased Risk For Breast Cancer
Effect of Weight Loss on Breast Density Using Both Digital Mammography and Breast MRI
NCT01259076CI-TRIAL-00017451terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was closed early due to slow accrual.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy, no Evidence of Disease | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| digital mammography | Procedure | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- Participants who are eligible for and have opted to undergo gastric bypass surgery
- interventionNames
- Procedure: magnetic resonance imaging
- Procedure: digital mammography
- Procedure: conventional surgery
- label
- Group 2
- description
- Participants who are eligible for but decided not to undergo gastric bypass surgery.
- interventionNames
- Procedure: magnetic resonance imaging
- Procedure: digital mammography
Primary outcomes (1)
- measure
- Change in BMI and breast density
- timeFrame
- At baseline and year 1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Women eligible for gastric bypass surgery * Pre-menopausal women * All women will have signed an informed consent form prior to participating in study procedures Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.