Breast CancerNCT01303419
Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
A study testing CE-BMRI and DE-CEDM in people with Breast Cancer, run by GE Healthcare at 5 sites in 5 countries.
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). Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CE-BMRI and DE-CEDM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Apr 2010to 30 Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
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
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).
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- CE-BMRI, DE-CEDM
- Keywords
- mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE-BMRIDevice
Contrast-enhanced breast imaging using Magnetic Resonance
DE-CEDMDevice
Breast imaging using Dual-energy, contrast-enhanced digital mammography
| Study group | Role | What they receive |
|---|---|---|
| CE-BMRI | Experimental | Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. Receives: Device: CE-BMRI; Device: DE-CEDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of CE-BMRI and DE-CEDM
Subjects have completed both CE-BMRI and DE-CEDM scan types
Measured: Approximately 8 weeks
Average Maximum Lesion Size by CE-BMRI Scan
Average maximum lesion size when scanned using CE-BMRI
Measured: Within 1 week of CE-BMRI scan
Average Maximum Lesion Size by DE-CEDM
Average maximum lesion size when scanned using DE-CEDM
Measured: Within 1 week of DE-CEDM scan
Average Maximum Lesion Size by Histology Outcome
Average maximum lesion size as described in histology report.
Measured: Approximately 1 week; upon completion of histology report
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.
Measured: This outcome did not occur due to premature study stop.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startApr 2010
- Primary completion30 Jun 2012
- Study completion30 Jun 2012
Why it stopped: Sponsor determined there was sufficient material collected to answer the study questions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303419
- Sponsor's protocol ID
- DE-CEDM-001
- Status last verified
- Mar 2019
- First submitted
- 18 Feb 2011
- Last updated
- 10 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01303419
- Acronym / sponsor ID
- DE-CEDM-001
- Conditions
- Breast Cancer
- Keywords
- mammography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor determined there was sufficient material collected to answer the study questions.
- Enrolment
- 224 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- 30 Jun 2012 (actual)
- Study completion
- 30 Jun 2012 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Posted 10 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CE-BMRI | Experimental | Device: CE-BMRI, Device: DE-CEDMSubject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CE-BMRIContrast-enhanced breast imaging using Magnetic Resonance | Device | CE-BMRI |
| DE-CEDMBreast imaging using Dual-energy, contrast-enhanced digital mammography | Device | CE-BMRI |
Primary outcome
Completion of CE-BMRI and DE-CEDM
Time frame: Approximately 8 weeks
Subjects have completed both CE-BMRI and DE-CEDM scan types
Average Maximum Lesion Size by CE-BMRI Scan
Time frame: Within 1 week of CE-BMRI scan
Average maximum lesion size when scanned using CE-BMRI
Average Maximum Lesion Size by DE-CEDM
Time frame: Within 1 week of DE-CEDM scan
Average maximum lesion size when scanned using DE-CEDM
Average Maximum Lesion Size by Histology Outcome
Time frame: Approximately 1 week; upon completion of histology report
Average maximum lesion size as described in histology report.
Multi-reader Evaluation of Images
Time frame: This outcome did not occur due to premature study stop.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CE-BMRI and DE-CEDM in people with Breast Cancer, run by GE Healthcare at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, Canada, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of CE-BMRI and DE-CEDM (time frame: Approximately 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.