Breast NeoplasmsNCT03929783
Contrast Enhanced Mammography in Diagnosing Patients With Suspicious Breast Findings
A study testing Contrast Enhanced Digital Mammography in people with Breast Neoplasms, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. Diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise… Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Contrast Enhanced Digital Mammography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2020to 27 Jan 2023
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with digital breast tomosynthesis and/or ultrasound assessments of Breast Imaging Reporting and Data System (BI-RADS) 4 and 5 lesions with recommendation of needle biopsy for tissue diagnosis.
- Abnormal findings include masses, focal, global or developing asymmetries, architecture distortions, or > 1 cm of suspicious calcifications with or without associated ultrasound abnormal findings.
- Scheduled for imaging guided percutaneous needle biopsy.
- Provide signed and dated informed consent form.
- If patient is of childbearing potential, a negative pregnancy test, urine or blood, within 14 days prior to the scan.
Who cannot join
- < 1 cm span of calcifications without an ultrasound correlate.
- Pregnant patients.
- Patients with known allergy to iodinated contrast material.
- If patient answers YES to any of the below questions they need glomerular filtration rate (gFR) prior to contrast administration regardless of their age:
- Have you ever been told you have renal problems?
- Have you ever been told you have protein in your urine?
Show all 10Show fewer
- Do you have high blood pressure?
- Do you have diabetes?
- Do you have gout?
- Have you ever had kidney surgery?
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Improving PPV3 Using Contrast Enhanced Mammography (CEM) in Diagnostic Assessment by Reducing Benign Tissue Diagnosis (FP3) - A Single-Arm Prospective Study
This pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. Diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise require biopsy for confirmation.
Read the detailed description
PRIMARY OBJECTIVES:
- To obtain preliminary data to support the hypothesis that contrast enhanced mammography (CEM) can reduce benign tissue diagnosis (FP3) and therefore improve positive predictive value 3 (PPV3).
SECONDARY OBJECTIVES:
- Identify specific CEM characteristics that accurately classify a finding as benign, high-risk or malignant.
II. Assess the positive and negative predictive values for each digital breast tomosynthesis (DBT), breast ultrasound and CEM.
EXPLORATORY OBJECTIVES:
- To compare the outcomes/endpoints stratified by age to determine if age affects the ability of CEM to accurately define a lesion as benign, probably benign or suspicious.
OUTLINE:
Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day or up to 3 days later.
- Conditions
- Breast Neoplasms
- Being tested
- Contrast Enhanced Digital 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.
Contrast Enhanced Digital MammographyProcedure or surgery
Also called CEDM, Contrast Enhanced Spectral Mammography
Undergo CEM
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (CEM) | Experimental | Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day. Receives: Procedure: Contrast Enhanced Digital Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious
The total number of suspicious and benign lesions on each modality (mammogram+ultrasound [MM+US] and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
Sensitivity of US to classify a lesion as benign, probably benign, or suspicious
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
Specificity of CEM to classify a lesion as benign, probably benign, or suspicious
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
Specificity of MM to classify a lesion as benign, probably benign, or suspicious
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
Specificity of US to classify a lesion as benign, probably benign, or suspicious
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
False negative rate of CEM
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
False negative rate of MM
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
False negative rate of US
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
False positive rate of CEM
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
False positive rate of MM
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
False positive rate of US
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Measured: Up to 1 year
Secondary outcomes (6)
Positive predictive value of CEM
The positive predictive value of CEM will be calculated and compared to MM+US.
Measured: Up to 1 year
Positive predictive value of MM
The positive predictive value of CEM will be calculated and compared to MM+US.
Measured: Up to 1 year
Positive predictive value of US
The positive predictive value of CEM will be calculated and compared to MM+US.
Measured: Up to 1 year
Negative predictive value of CEM
The negative predictive value of CEM will be calculated and compared to MM+US.
Measured: Up to 1 year
Negative predictive value of MM
The negative predictive value of CEM will be calculated and compared to MM+US.
Measured: Up to 1 year
Negative predictive value of US
The negative predictive value of CEM will be calculated and compared to MM+US.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start23 Jun 2020
- Primary completion31 Dec 2021
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lydia Liao, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929783
- Sponsor's protocol ID
- 19D.203
- Other IDs
- JT 13786
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2019
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving PPV3 Using Contrast Enhanced Mammography (CEM) in Diagnostic Assessment by Reducing Benign Tissue Diagnosis (FP3) - A Single-Arm Prospective Study
- ClinicalTrials.gov ID
- NCT03929783
- Acronym / sponsor ID
- 19D.203
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 29 Apr 2019 (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.
This pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. Diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise require biopsy for confirmation.
Detailed description
PRIMARY OBJECTIVES:
- To obtain preliminary data to support the hypothesis that contrast enhanced mammography (CEM) can reduce benign tissue diagnosis (FP3) and therefore improve positive predictive value 3 (PPV3).
SECONDARY OBJECTIVES:
- Identify specific CEM characteristics that accurately classify a finding as benign, high-risk or malignant.
II. Assess the positive and negative predictive values for each digital breast tomosynthesis (DBT), breast ultrasound and CEM.
EXPLORATORY OBJECTIVES:
- To compare the outcomes/endpoints stratified by age to determine if age affects the ability of CEM to accurately define a lesion as benign, probably benign or suspicious.
OUTLINE:
Patients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day or up to 3 days later.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CEM) | Experimental | Procedure: Contrast Enhanced Digital MammographyPatients undergo contrast enhanced mammography prior to scheduled standard of care core needle biopsy of the breast on the same day. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women with digital breast tomosynthesis and/or ultrasound assessments of Breast Imaging Reporting and Data System (BI-RADS) 4 and 5 lesions with recommendation of needle biopsy for tissue diagnosis.
- Abnormal findings include masses, focal, global or developing asymmetries, architecture distortions, or > 1 cm of suspicious calcifications with or without associated ultrasound abnormal findings.
- Scheduled for imaging guided percutaneous needle biopsy.
- Provide signed and dated informed consent form.
- If patient is of childbearing potential, a negative pregnancy test, urine or blood, within 14 days prior to the scan.
Key exclusion criteria (10 listed)
- < 1 cm span of calcifications without an ultrasound correlate.
- Pregnant patients.
- Patients with known allergy to iodinated contrast material.
- If patient answers YES to any of the below questions they need glomerular filtration rate (gFR) prior to contrast administration regardless of their age:
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 Digital MammographyAlso: CEDM, Contrast Enhanced Spectral MammographyUndergo CEM | Procedure or surgery | Diagnostic (CEM) |
Primary outcome
Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (mammogram+ultrasound [MM+US] and CEM) will be calculated and compared to a final tissue diagnosis independently.
Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Sensitivity of US to classify a lesion as benign, probably benign, or suspicious
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Specificity of CEM to classify a lesion as benign, probably benign, or suspicious
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Specificity of MM to classify a lesion as benign, probably benign, or suspicious
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Specificity of US to classify a lesion as benign, probably benign, or suspicious
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False negative rate of CEM
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False negative rate of MM
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False negative rate of US
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False positive rate of CEM
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False positive rate of MM
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False positive rate of US
Time frame: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
6 secondary outcomes
Positive predictive value of CEM
Time frame: Up to 1 year
Positive predictive value of MM
Time frame: Up to 1 year
Positive predictive value of US
Time frame: Up to 1 year
Negative predictive value of CEM
Time frame: Up to 1 year
Negative predictive value of MM
Time frame: Up to 1 year
Negative predictive value of US
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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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.
Lydia Liao principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast Enhanced Digital Mammography in people with Breast Neoplasms, run by Thomas Jefferson University 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 29 Apr 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious (time frame: Up to 1 year). The study lists 12 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 29 Apr 2025.