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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01970670
First received: October 22, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Phase
Breast - Female
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Contrast-Enhanced Digital Mammography (CEDM) vs Contrast-Enhanced Breast MRI (CE-MRI) in Patients With Known Breast Cancer

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Number of partipicants with adverse events [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult women, ages18-70 years old, of any race and ethnicity, with a recent diagnosis of breast cancer (histologically confirmed invasive and/or in situ carcinoma of the breast)who have not undergone surgery, are not planned to undergo neoadjuvant chemotherapy; and have a CE-MRI within 1 month(31 days) of enrollment.

Criteria

Identify 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

Identify 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970670

Locations
United States, California
Stanford University Cancer Institute Not yet recruiting
Stanford, California, United States, 94305
Contact: Sumita Sood    650-723-0186    ssood@stanford.edu   
Principal Investigator: Jafi Lipson         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jafi Lipson Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01970670     History of Changes
Other Study ID Numbers: BRS0031, 27277
Study First Received: October 22, 2013
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014