---
title: Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography
nct_id: NCT02995980
overall_status: COMPLETED
phase: NA
sponsor: University of Alabama at Birmingham
study_type: INTERVENTIONAL
primary_condition: Breast Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02995980.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02995980"
ct_last_update_post_date: 2019-09-25
last_seen_at: "2026-05-12T06:12:36.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography

**Official Title:** Pilot Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography to Detect Breast Cancer in Patients With Increased Breast Density (Breast Imaging-Reporting And Data System (BI-RADS) Category c or d)

**NCT ID:** [NCT02995980](https://clinicaltrials.gov/study/NCT02995980)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 128
- **Lead Sponsor:** University of Alabama at Birmingham
- **Conditions:** Breast Cancer
- **Start Date:** 2015-11
- **Completion Date:** 2018-05-31
- **CT.gov Last Update:** 2019-09-25

## Brief Summary

This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (BI-RADS category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer.

## Detailed Description

This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (Breast Imaging-Reporting And Data System category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

1. Signed informed consent
2. At least 19 years old
3. Glomerular filtration rate\> 60
4. Heterogeneously or extremely dense breasts (BI-RADS category c or d).

Exclusion Criteria:

1. History of iodinated contrast allergy
2. Pregnant or lactating as determined by routine standard practice
3. Personal history of breast cancer
4. History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)
5. History of prior breast reduction mammoplasty surgery
6. History of prior breast augmentation surgery
7. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
```

## Arms

- **Contrast enhanced mammography vs standard digital mammogram** (EXPERIMENTAL) — Contrast-enhanced spectral mammography for the detection breast cancer .

## Interventions

- **Dual-Energy Contrast-Enhanced (DECE) mammography** (DEVICE) — Contrast mammography
- **digital mammography** (DEVICE) — routine digital mammography

## Primary Outcomes

- **Percent Accuracy of Contrast Mammography** _(time frame: 1 year)_ — •The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).
- **Number of Participants With Cancer Detected** _(time frame: 1 year)_ — •The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).

## Secondary Outcomes

- **Number of Call Backs With Contrast Mammography** _(time frame: 1 year)_

## Locations (1)

- The Kirklin Clinic, Birmingham, Alabama, United States

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the kirklin clinic|birmingham|alabama|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02995980*  
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