Breast CancerNCT04770714
Prospective Comparison of Breast MRI vs Contrast Mammography Prior to Surgery in Breast Cancer Patients
A study testing Breast MRI and Contrast Enhanced Mammography in people with Breast Cancer, run by University of Arizona at 1 site in United States.
Trial summary
In current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast MRI and Contrast Enhanced Mammography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older with newly diagnosed breast cancer and planned breast conservation surgery
- Clinically indicated referral for breast MRI or contrast mammogram prior to surgery
- Provision of informed consent
Who cannot join
- Planned neoadjuvant chemotherapy
- Patients that are medically unstable
- Pregnancy
- Patients with known contraindication to contrast mammography, including:
- Glomerular filtration rate <30
- Known adverse reaction to iodinated contrast material
Show all 15Show fewer
- Patients with known contraindication to Breast MRI including:
- Glomerular filtration rate <30
- Known adverse reaction to gadolinium contrast material
- Non-MRI conditional device or catheter
- Brain aneurysm clip implanted before 1995
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Insulin pump
- Patients unable to read and understand English or Spanish (i.e. an inability to complete study questionnaires)
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center Phoenixq
Phoenix, Arizona, 85006
About this study
Official title: Comparison of Breast MRI Versus Contrast Enhanced Mammography Prior to Surgery in Breast Cancer Patients: a Randomized Controlled Trial
In current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. This study seeks to compare the global costs (based on actual reimbursement rates) of CEM/breast MRI, downstream imaging testing, and diagnostic procedures in women randomized to breast MRI versus CEM. Secondary goals are to compare patient preferences for CEM vs MRI and clinically relevant outcomes (e.g. conversion from lumpectormy to mastecomy).
Read the detailed description
This is a pilot randomized controlled trial comparing the global costs of two standard of care imaging techniques in patients with a new breast cancer diagnosis and planned breast conservation surgery. Patients enrolled in this study will be randomized to either CEM or breast MRI. The purpose of this study is to compare the global costs (based on actual reimbursement rates) of initial imaging modality (CEM or breast MRI), downstream imaging related to breast cancer evaluation, and diagnostic breast procedures in women randomized to breast MRI versus CEM.
Secondary endpoints include assessment of patient's reported satisfaction with the initial imaging technique received (CEM versus MRI), quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire), rate of conversion from planned lumpectomy to mastectomy, and rate of re-operation for positive margins.
- Conditions
- Breast Cancer
- Being tested
- Breast MRI, Contrast Enhanced 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.
Breast MRIDiagnostic test
Standard of Care Breast MRI
Contrast Enhanced MammographyDiagnostic test
Standard of Care Contrast Enhanced Mammography
| Study group | Role | What they receive |
|---|---|---|
| Breast MRI | Other | Patients in this arm will be randomized to receive a Breast MRI in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers Receives: Diagnostic Test: Breast MRI |
| Contrast Enhanced Mammography | Other | Patients in this arm will be randomized to receive a Contrast Enhanced Mammograph in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers Receives: Diagnostic Test: Contrast Enhanced Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Costs
The Primary outcome is to compare the global costs (based on actual reimbursement rates) of initial imaging modality (CEM or breast MRI), downstream imaging related to breast cancer evaluation, and diagnostic breast procedures in women randomized to breast MRI versus CEM.
Measured: Through Study Completion (2 years)
Secondary outcomes (4)
Patient Satisfaction using modified Likert scale
Patient's reported satisfaction with the initial imaging technique received (CEM versus MRI) will be assessed via Post-Imaging questionnaires designed to gauge patient's opinions about the imaging technique they received.
Measured: Through Study Completion (2 years)
Health-Related Quality of Life
quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire)
Measured: Through Study Completion (2 years)
Rate of Conversion
Rate of conversion from planned lumpectomy to mastectomy
Measured: Through Study Completion (2 years)
Rate of Re-Operation
rate of re-operation for positive margins
Measured: Through Study Completion (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start19 Jan 2021
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: No Participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Morris, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770714
- Sponsor's protocol ID
- 2010134480
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2021
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study results will be shared on ClinicalTrials.gov in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Breast MRI Versus Contrast Enhanced Mammography Prior to Surgery in Breast Cancer Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04770714
- Acronym / sponsor ID
- 2010134480
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. This study seeks to compare the global costs (based on actual reimbursement rates) of CEM/breast MRI, downstream imaging testing, and diagnostic procedures in women randomized to breast MRI versus CEM. Secondary goals are to compare patient preferences for CEM vs MRI and clinically relevant outcomes (e.g. conversion from lumpectormy to mastecomy).
Detailed description
This is a pilot randomized controlled trial comparing the global costs of two standard of care imaging techniques in patients with a new breast cancer diagnosis and planned breast conservation surgery. Patients enrolled in this study will be randomized to either CEM or breast MRI. The purpose of this study is to compare the global costs (based on actual reimbursement rates) of initial imaging modality (CEM or breast MRI), downstream imaging related to breast cancer evaluation, and diagnostic breast procedures in women randomized to breast MRI versus CEM.
Secondary endpoints include assessment of patient's reported satisfaction with the initial imaging technique received (CEM versus MRI), quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire), rate of conversion from planned lumpectomy to mastectomy, and rate of re-operation for positive margins.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast MRI | Other | Diagnostic Test: Breast MRIPatients in this arm will be randomized to receive a Breast MRI in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers |
| Contrast Enhanced Mammography | Other | Diagnostic Test: Contrast Enhanced MammographyPatients in this arm will be randomized to receive a Contrast Enhanced Mammograph in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 18 years or older with newly diagnosed breast cancer and planned breast conservation surgery
- Clinically indicated referral for breast MRI or contrast mammogram prior to surgery
- Provision of informed consent
Key exclusion criteria (15 listed)
- Planned neoadjuvant chemotherapy
- Patients that are medically unstable
- Pregnancy
- Patients with known contraindication to contrast mammography, including:
- Patients with known contraindication to Breast MRI including:
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 |
|---|---|---|
| Breast MRIStandard of Care Breast MRI | Diagnostic test | Breast MRI |
| Contrast Enhanced MammographyStandard of Care Contrast Enhanced Mammography | Diagnostic test | Contrast Enhanced Mammography |
Primary outcome
Global Costs
Time frame: Through Study Completion (2 years)
The Primary outcome is to compare the global costs (based on actual reimbursement rates) of initial imaging modality (CEM or breast MRI), downstream imaging related to breast cancer evaluation, and diagnostic breast procedures in women randomized to breast MRI versus CEM.
4 secondary outcomes
Patient Satisfaction using modified Likert scale
Time frame: Through Study Completion (2 years)
Health-Related Quality of Life
Time frame: Through Study Completion (2 years)
Rate of Conversion
Time frame: Through Study Completion (2 years)
Rate of Re-Operation
Time frame: Through Study Completion (2 years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No. Study results will be shared on ClinicalTrials.gov in aggregate form.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast MRI and Contrast Enhanced Mammography in people with Breast Cancer, run by University of Arizona at 1 site in United States.
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 3 inclusion and 15 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: withdrawn, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Global Costs (time frame: Through Study Completion (2 years)). 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 29 Feb 2024.