Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Multicenter, Open-Label, Crossover Trial to Assess Non-Inferiority of Dual Energy Contrast-Enhanced Digital Mammography (DE-CEDM) Compared to Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) for Identifying a Change in Patient Management in Women With Newly Diagnosed Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01303419
• Other study ID #: DE-CEDM-001
• Status: Terminated
• Phase: N/A
• Start date: April 2010
• Est. completion date: June 30, 2012

Study information

• Verified date: March 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).

Description:

Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM). Maximum lesion size was compared between the two imaging types. Subject data from both scans was planned to be included in a multi-reader evaluation; however, due to premature stop of the study, multi-reader data was not collected.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 224
• Est. completion date: June 30, 2012
• Est. primary completion date: June 30, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Woman 21 years of age or older

• The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.

• Newly diagnosed with Breast Cancer (DCIS or invasive) identified through core biopsy or fine-needle aspiration (FNA) within last 30 days.

• Will have or have had a bilateral CE-BMRI performed within 30 days AFTER the new breast cancer diagnosis.

Exclusion Criteria:

• Woman who has already had a lumpectomy for the index lesion.

• Woman undergoing neoadjuvant chemotherapy treatment, hormone treatment or radiation therapy.

• Woman who is pregnant or who believe she may be pregnant.

• Woman who has breast implant.

• Woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• CE-BMRI
Contrast-enhanced breast imaging using Magnetic Resonance
• DE-CEDM
Breast imaging using Dual-energy, contrast-enhanced digital mammography

Locations

Country	Name	City	State
Belgium	AZ St-Jan Brugge AV	Brugge
Canada	Sunnybrook Health Science Centre	Toronto
France	Institut Goustave Roussy	Villejuif
Germany	Institut fur Radiologie, Charite	Berlin
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of CE-BMRI and DE-CEDM	Subjects have completed both CE-BMRI and DE-CEDM scan types	Approximately 8 weeks
Primary	Average Maximum Lesion Size by CE-BMRI Scan	Average maximum lesion size when scanned using CE-BMRI	Within 1 week of CE-BMRI scan
Primary	Average Maximum Lesion Size by DE-CEDM	Average maximum lesion size when scanned using DE-CEDM	Within 1 week of DE-CEDM scan
Primary	Average Maximum Lesion Size by Histology Outcome	Average maximum lesion size as described in histology report.	Approximately 1 week; upon completion of histology report
Primary	Multi-reader Evaluation of Images	Multi-reader evaluation of images and comparison between CE-BMRI vs. DE-CEDM to determine which technology can more precisely measure cancer size as determined by pathological examination was planned. This was not conducted due to premature stop of the study.	This outcome did not occur due to premature study stop.