Clinical trial · Interventional
Role of Contrast Enhanced Spectral Mammography to Predict Upgrade Rates of Biopsy Proven Atypical Ductal Hyperplasia
NCT03505372CI-TRIAL-00043340terminatedN/AResults postedClinicalTrials.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): Unable to recruit to study due to limited number of patients with ADH
Summary
Brief summary (as posted)
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
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 |
|---|---|---|---|
| Atypical Ductal Hyperplasia | Breast Atypical Ductal Hyperplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast enhanced mammography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast enhanced mammography
- description
- * The CESM images will be performed according to clinical protocol * Images will be acquired within approximately 2-12 minutes of contrast injection * A total of four images per breast will be acquired with low and high energy * Two radiologists will prospectively review the CESM, and will use a third as tie-breaker * The CESM will be evaluated for the biopsy site and up to two additional findings in either breast * The biopsy site will be evaluated for abnormal findings that would suggest malignant involvement
- interventionNames
- Device: Contrast enhanced mammography
Primary outcomes (1)
- measure
- CESM's Ability to Predict Upgrade Rates of Biopsy Proven ADH at Surgical Excision
- timeFrame
- 3 months
- description
- Investigators will evaluate whether enhancement on CESM can predict which cases of ADH upgrade at the time of surgical excision.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
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 associated malignancy (in the same quadrant) will be excluded. * Participant had a breast MRI that was performed after the diagnosis of ADH but before surgical excision * Participants who have a known allergy to contrast media. * Participants who have a known severe allergic response to one or more allergens, as defined by anaphylaxis. * Participants with persistent asthma as defined by the National Heart, Lung, and Blood Institute. * Participants with renal insufficiency or failure, as determined by a point of care renal function blood test. * Participants who are breastfeeding are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to contrast administration in the mother. * Participants with the following underlying medical conditions: multiple myeloma, myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, cardiac arrythmia, or severe cardiomyopathy. These underlying medical conditions may make the participant more likely to develop a contrast reaction. This is based on the ACR contrast manual version 10.3 and hospital policy. * Participants with thyroid carcinoma or thyroid disease for whom systemic radioactive iodine therapy is part of planned diagnostic work-up or treatment within 2 months following the contrast mammogram study. * Participants with a concurrent active illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, thyroid storm. * Pregnant women are excluded from this study because CESM uses radiation with the potential for teratogenic or abortifacient effects. This will be defined by a urine pregnancy test prior to the CESM study.
References
Publications (0)
Data not yet available
No reference posted for this study.