Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical… (NCT03505372) | Clinical Trial Compass
TerminatedNot Applicable
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia
Stopped: Unable to recruit to study due to limited number of patients with ADH
United States5 participantsStarted 2018-05-10
Plain-language summary
This research study is studying whether contrast enhanced mammography can predict if atypical ductal hyperplasia will progress to cancer.
The device involved in this study is:
-Contrast enhanced mammography
Who can participate
Age range30 Years
SexFEMALE
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Inclusion Criteria:
* Age, Minimum 30 years. CESM is an imaging exam that uses radiation and is not typically employed in women younger than age 30 due to potentially negative biologic effects on glandular breast tissue.
* Participants who had a percutaneous breast biopsy (to include stereotactic, tomosynthesis, or ultrasound guided) that revealed ADH
* Participants will be undergoing surgical excision to remove the ADH.
* Participants must have normal organ and marrow function as defined by a GFR ≥60 mL/min/1.73 m2 to be performed per clinical protocol
* Patients ≥65 years without underlying renal insufficiency get GFR tested within 6 months of the exam.
* Patients \< 65 years without underlying renal insufficiency do not require an GFR calculation)
* Patients ≥65 years with known underlying renal insufficiency get GFR tested within 1 month of the exam.
* Patients \< 65 years with known renal insufficiency get GFR tested within 1 month of the exam.
* Because of the potential teratogenic effects of radiation, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, until the CESM is performed. Should a woman become pregnant or suspect she is pregnant, she should inform the study team prior to getting the CESM.
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Participants with a core biopsy diagnosis of atypia with ass…
What they're measuring
1
CESM's Ability to Predict Upgrade Rates of Biopsy Proven ADH at Surgical Excision