## Protocol Section
### Identification Module
**NCT ID:** NCT03176979

**Brief Title:** Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer

**Official Title:** Emerging Tools in the Detection of Breast Cancer: Comparison of Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis to Conventional Imaging Techniques Including Contrast Enhanced Magnetic Resonance Imaging and 2D Mammography With or Without Targeted Ultrasound

#### Organization Study ID Info
**ID:** 1B-16-3
#### Organization
**Class:** OTHER
**Full Name:** University of Southern California
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2017-00778
**Type:** REGISTRY
**Domain:** USC / Norris Comprehensive Cancer Center
**ID:** 1B-16-3
**Type:** OTHER
**ID:** P30CA014089
**Link:** https://reporter.nih.gov/quickSearch/P30CA014089
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2021-07-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-11-18

**Type:** ACTUAL

**Last Update Submit Date:** 2021-11-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-07-08

**Type:** ACTUAL

#### Start Date
**Date:** 2017-04-21

**Type:** ACTUAL

**Status Verified Date:** 2021-11

#### Study First Post Date
**Date:** 2017-06-06
**Type:** ACTUAL
**Study First Submit Date:** 2017-06-02
**Study First Submit QC Date:** 2017-06-02
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Southern California

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This pilot clinical trial studies how well contrast enhanced spectral mammography works with digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast enhanced spectral mammography uses a special dye that is injected into the veins before mammogram images are taken. Digital breast tomosynthesis uses multiple x-ray pictures to produce a 3-dimensional rendering of the entire breast. Contrast enhanced spectral mammography with digital breast tomosynthesis may highlight areas of concern within the breast in more detail than a standard mammogram and improve the accuracy of tumor size.

**Detailed Description:** PRIMARY OBJECTIVES:

I. To compare the index lesion size (the largest diameter) from each of the four readings (standard of care 2 dimensional \[D\], magnetic resonance imaging \[MRI\], contrast enhanced spectral mammography \[CESM\], 3D) to gold standard index lesion size from surgical pathology (the largest diameter).

II. To document the additional ipsilateral and contralateral breast cancer lesions detected by the MRI, CESM, and 3D readings listed above.

OUTLINE:

Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent intravenously (IV) and then undergo a CESM with digital breast tomosynthesis (DBT) over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast contrast enhanced (CE)-MRI over 10 minutes.

After completion of study, patients are followed up within 24-96 hours.

### Conditions Module

**Conditions:**

- Breast Carcinoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 43

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent IV and then undergo a CESM with DBT over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast CE-MRI over 10 minutes.

**Intervention Names:**

- Other: Contrast Agent

- Procedure: Digital Tomosynthesis Mammography

- Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography

**Label:** Diagnostic (CESM with DBT)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Diagnostic (CESM with DBT)

**Description:** Given IV

**Name:** Contrast Agent

**Other Names:**

- Contrast

- Contrast Drugs

- contrast material

- Contrast Medium

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Diagnostic (CESM with DBT)

**Description:** Undergo CESM with DBT

**Name:** Digital Tomosynthesis Mammography

**Other Names:**

- DBT

- Digital Breast Tomosynthesis

- Digital Tomosynthesis of the Breast

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Diagnostic (CESM with DBT)

**Description:** Undergo CESM with DBT

**Name:** Dual-Energy Contrast-Enhanced Digital Spectral Mammography

**Other Names:**

- Dual-Energy Contrast-Enhanced Digital Mammography (CEDM)

- Dual-Energy Contrast-Enhanced Digital Subtraction Mammography

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Intra-class correlation will be used to assess the agreement of index lesion size from each imaging reading to the gold standard (histopathology at surgery). Bland-Altman plot will be used to illustrate the pattern of difference between each reading and the gold standard.

**Measure:** Index lesion size using the largest diameter

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Newly diagnosed breast cancer patients

Exclusion Criteria:

* Women with history of surgical, medical, or radiation therapy for breast cancer
* Women with renal failure or insufficiency
* Women with iodine contrast allergy
* Women with gadolinium contrast allergy
* Women who are pregnant, possibly pregnant, or lactating
* Women undergoing neoadjuvant chemotherapy

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** USC / Norris Comprehensive Cancer Center

**State:** California

**Zip:** 90033

#### Overall Officials

**Official 1:**

**Affiliation:** University of Southern California

**Name:** Mary Yamashita, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Carcinoma

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
