Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

NCT ID: NCT01970670

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-08-18

Brief Summary

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Detailed Description

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Conditions

Breast - Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed invasive and/or in situ carcinoma of the breast

2. Any race and ethnicity

3. Females 18-70 years of age

4. Willing and able to provide informed consent

5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment or procedure between the CEDM and CE-MRI

Exclusion Criteria

1. Unwilling or unable to undergo informed consent

2. Planned to undergo neoadjuvant chemotherapy

3. Breast implants

4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be performed for confirmation.)

5. Breast-feeding

6. Surgical excision of the biopsy proven malignancy

7. Known allergy to gadolinium contrast agents

8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other ferromagnetic surgical implant or severe claustrophobia)

9. Suspected to be at risk to complications from the contrast agent. These include the standard iodinated contrast agent contraindications:

1. Subject has renal insufficiency as determined by an elevated serum creatinine and is not being treated with dialysis.

2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be required for any subject with any of the following risk factors for renal insufficiency:

i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c. Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or severe asthma regularly treated with medication f. Subject has had an episode of serious allergic reaction (anaphylaxis) to any substance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jafi Lipson

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

27277

Identifier Type: -

Identifier Source: secondary_id

BRS0031

Identifier Type: -

Identifier Source: org_study_id