MammographyNCT03639129
Improving Characterization of Calcifications With Contrast-Enhanced Mammography
A study testing Contrast-enhanced mammography and Biopsy in people with Mammography, run by Washington University School of Medicine.
Trial summary
The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Mammography
- What is being tested?
- Contrast-enhanced mammography and Biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2019to 31 May 2021
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography.
- At least 30 years of age.
- Able to understand and willing to sign an IRB-approved written informed consent document
- GFR ≥ 30 mL/min/1.73 m2
Who cannot join
- Pregnant
- Prior history of allergy or hypersensitivity reaction to iodinated contrast
- History of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery)
- Patients with known thyroid disorders, pheochromocytoma or sickle cell anemia
About this study
The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.
- Conditions
- Mammography
- Being tested
- Contrast-enhanced mammography, Biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced mammographyDevice
Also called CME
Contrast-enhanced mammography was FDA approved in 2012 and is currently being used in both clinical and research settings at breast imaging centers throughout the world
BiopsyProcedure or surgery
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Contrast-enhanced mammography (CME) | Experimental | -Patients who meet eligibility criteria and consent to participate in this study will complete a CEM examination prior to or on the day that biopsy is scheduled. CEM must occur no later than 60 days after the diagnostic mammogram. The standard of care biopsy must occur no later than 30 days after CEM. Receives: Device: Contrast-enhanced mammography; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate risk characterization of screen-detected calcifications by CEM
-The proportion of women with abnormal enhancement (yes/no) will be compared to the pathology results from the core needle biopsy (benign versus high risk/malignant)
Measured: Up to 30 days after the CEM
Secondary outcomes (3)
Rate of detection of additional sites of disease in the same or contralateral breast on CEM
This will be defined as presence of abnormal enhancement in the same breast at least 2 cm away from the margin of the calcifications of interest or any presence of abnormal enhancement in the contralateral breast at the time of CEM
-The reference standard in this case will also be based on pathology results from core needle biopsy (if additional biopsies are performed) or findings on surgical pathology if the patient elects for mastectomy, with the decision for core needle biopsy and lumpectomy vs mastectomy according to surgeon preference and standard of care.
Measured: At the time of the CEM (day 1)
Ability of CEM to determine whether accuracy for cancer detection varies as a function of breast density
-Breast density category is routinely reported in the screening mammography report and accepted categories include predominantly fatty, scattered fibroglandular densities, heterogeneously dense, and extremely dense.
Measured: At the time of the CEM (day 1)
Ability of whether CEM accuracy for cancer detection varies as a function of the morphology of calcifications as depicted on screening and diagnostic mammography
-Morphology of calcifications include amorphous, coarse heterogeneous, fine pleomorphic, or fine linear branching and/or based on distribution of the calcifications as either diffuse, regional, grouped, linear, or segmental, according to the descriptors in the imaging reports
Measured: At the time of the CEM (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start31 May 2019 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammographyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Covington, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639129
- Sponsor's protocol ID
- 201709088
- Status last verified
- May 2019
- First submitted
- 31 Jul 2018
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Characterization of Calcifications With Contrast-Enhanced Mammography
- ClinicalTrials.gov ID
- NCT03639129
- Acronym / sponsor ID
- 201709088
- Conditions
- Mammography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 31 May 2019 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 20 Aug 2018 (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.
The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast-enhanced mammography (CME) | Experimental | Device: Contrast-enhanced mammography, Procedure: Biopsy-Patients who meet eligibility criteria and consent to participate in this study will complete a CEM examination prior to or on the day that biopsy is scheduled. CEM must occur no later than 60 days after the diagnostic mammogram. The standard of care biopsy must occur no later than 30 days after CEM. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography.
- At least 30 years of age.
- Able to understand and willing to sign an IRB-approved written informed consent document
- GFR ≥ 30 mL/min/1.73 m2
Key exclusion criteria (4 listed)
- Pregnant
- Prior history of allergy or hypersensitivity reaction to iodinated contrast
- History of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery)
- Patients with known thyroid disorders, pheochromocytoma or sickle cell anemia
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 |
|---|---|---|
| Contrast-enhanced mammographyAlso: CMEContrast-enhanced mammography was FDA approved in 2012 and is currently being used in both clinical and research settings at breast imaging centers throughout the world | Device | Contrast-enhanced mammography (CME) |
| BiopsyStandard of care | Procedure or surgery | Contrast-enhanced mammography (CME) |
Primary outcome
Evaluate risk characterization of screen-detected calcifications by CEM
Time frame: Up to 30 days after the CEM
-The proportion of women with abnormal enhancement (yes/no) will be compared to the pathology results from the core needle biopsy (benign versus high risk/malignant)
3 secondary outcomes
Rate of detection of additional sites of disease in the same or contralateral breast on CEM
Time frame: At the time of the CEM (day 1)
Ability of CEM to determine whether accuracy for cancer detection varies as a function of breast density
Time frame: At the time of the CEM (day 1)
Ability of whether CEM accuracy for cancer detection varies as a function of the morphology of calcifications as depicted on screening and diagnostic mammography
Time frame: At the time of the CEM (day 1)
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 14 May 2019.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Matthew Covington, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced mammography and Biopsy in people with Mammography, run by Washington University School of Medicine.
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 4 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 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluate risk characterization of screen-detected calcifications by CEM (time frame: Up to 30 days after the CEM). 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 14 May 2019.