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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 November 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01970670
First received: October 22, 2013
Last updated: November 24, 2014
Last verified: November 2014

October 22, 2013
November 24, 2014
December 2014
November 2016   (final data collection date for primary outcome measure)
Number of partipicants with adverse events [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01970670 on ClinicalTrials.gov Archive Site
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Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer
Contrast-Enhanced Digital Mammography (CEDM) vs Contrast-Enhanced Breast MRI (CE-MRI) in Patients With Known Breast Cancer

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Breast - Female
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
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November 2016   (final data collection date for primary outcome measure)

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

Female
18 Years to 70 Years
No
United States
 
NCT01970670
BRS0031, 27277
No
Stanford University
Stanford University
Not Provided
Principal Investigator: Jafi Lipson Stanford University
Stanford University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP