Breast CarcinomaNCT03176979
Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer
A study testing Contrast Agent, Digital Tomosynthesis Mammography and Dual-Energy Contrast-Enhanced Digital Spectral Mammography in people with Breast Carcinoma, run by University of Southern California at 1 site in United States.
Trial summary
This pilot clinical trial studies how well contrast enhanced spectral mammography works with digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast enhanced spectral mammography uses a special dye that is injected into the veins before mammogram images are taken. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Contrast Agent, Digital Tomosynthesis Mammography and Dual-Energy Contrast-Enhanced Digital Spectral Mammography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2017to 8 Jul 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed breast cancer patients
Who cannot join
- Women with history of surgical, medical, or radiation therapy for breast cancer
- Women with renal failure or insufficiency
- Women with iodine contrast allergy
- Women with gadolinium contrast allergy
- Women who are pregnant, possibly pregnant, or lactating
- Women undergoing neoadjuvant chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Emerging Tools in the Detection of Breast Cancer: Comparison of Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis to Conventional Imaging Techniques Including Contrast Enhanced Magnetic Resonance Imaging and 2D Mammography With or Without Targeted Ultrasound
This pilot clinical trial studies how well contrast enhanced spectral mammography works with digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast enhanced spectral mammography uses a special dye that is injected into the veins before mammogram images are taken. Digital breast tomosynthesis uses multiple x-ray pictures to produce a 3-dimensional rendering of the entire breast. Contrast enhanced spectral mammography with digital breast tomosynthesis may highlight areas of concern within the breast in more detail than a standard mammogram and improve the accuracy of tumor size.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the index lesion size (the largest diameter) from each of the four readings (standard of care 2 dimensional [D], magnetic resonance imaging [MRI], contrast enhanced spectral mammography [CESM], 3D) to gold standard index lesion size from surgical pathology (the largest diameter).
II. To document the additional ipsilateral and contralateral breast cancer lesions detected by the MRI, CESM, and 3D readings listed above.
OUTLINE:
Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent intravenously (IV) and then undergo a CESM with digital breast tomosynthesis (DBT) over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast contrast enhanced (CE)-MRI over 10 minutes.
After completion of study, patients are followed up within 24-96 hours.
- Conditions
- Breast Carcinoma
- Being tested
- Contrast Agent, Digital Tomosynthesis Mammography, Dual-Energy Contrast-Enhanced Digital Spectral 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 AgentOther
Also called Contrast, Contrast Drugs, contrast material, Contrast Medium
Given IV
Digital Tomosynthesis MammographyProcedure or surgery
Also called DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the Breast
Undergo CESM with DBT
Dual-Energy Contrast-Enhanced Digital Spectral MammographyProcedure or surgery
Also called Dual-Energy Contrast-Enhanced Digital Mammography (CEDM), Dual-Energy Contrast-Enhanced Digital Subtraction Mammography
Undergo CESM with DBT
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (CESM with DBT) | Experimental | Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent IV and then undergo a CESM with DBT over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast CE-MRI over 10 minutes. Receives: Other: Contrast Agent; Procedure: Digital Tomosynthesis Mammography; Procedure: Dual-Energy Contrast-Enhanced Digital Spectral Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index lesion size using the largest diameter
Intra-class correlation will be used to assess the agreement of index lesion size from each imaging reading to the gold standard (histopathology at surgery). Bland-Altman plot will be used to illustrate the pattern of difference between each reading and the gold standard.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start21 Apr 2017
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mary Yamashita, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176979
- Sponsor's protocol ID
- 1B-16-3
- Other IDs
- NCI-2017-00778, 1B-16-3, P30CA014089
- Status last verified
- Nov 2021
- First submitted
- 2 Jun 2017
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emerging Tools in the Detection of Breast Cancer: Comparison of Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis to Conventional Imaging Techniques Including Contrast Enhanced Magnetic Resonance Imaging and 2D Mammography With or Without Targeted Ultrasound
- ClinicalTrials.gov ID
- NCT03176979
- Acronym / sponsor ID
- 1B-16-3
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 6 Jun 2017 (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 clinical trial studies how well contrast enhanced spectral mammography works with digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast enhanced spectral mammography uses a special dye that is injected into the veins before mammogram images are taken. Digital breast tomosynthesis uses multiple x-ray pictures to produce a 3-dimensional rendering of the entire breast. Contrast enhanced spectral mammography with digital breast tomosynthesis may highlight areas of concern within the breast in more detail than a standard mammogram and improve the accuracy of tumor size.
Detailed description
PRIMARY OBJECTIVES:
- To compare the index lesion size (the largest diameter) from each of the four readings (standard of care 2 dimensional [D], magnetic resonance imaging [MRI], contrast enhanced spectral mammography [CESM], 3D) to gold standard index lesion size from surgical pathology (the largest diameter).
II. To document the additional ipsilateral and contralateral breast cancer lesions detected by the MRI, CESM, and 3D readings listed above.
OUTLINE:
Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent intravenously (IV) and then undergo a CESM with digital breast tomosynthesis (DBT) over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast contrast enhanced (CE)-MRI over 10 minutes.
After completion of study, patients are followed up within 24-96 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CESM with DBT) | Experimental | Other: Contrast Agent, Procedure: Digital Tomosynthesis Mammography, Procedure: Dual-Energy Contrast-Enhanced Digital Spectral MammographyPatients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent IV and then undergo a CESM with DBT over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast CE-MRI over 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed breast cancer patients
Key exclusion criteria (6 listed)
- Women with history of surgical, medical, or radiation therapy for breast cancer
- Women with renal failure or insufficiency
- Women with iodine contrast allergy
- Women with gadolinium contrast allergy
- Women who are pregnant, possibly pregnant, or lactating
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 AgentAlso: Contrast, Contrast Drugs, contrast material, Contrast MediumGiven IV | Other | Diagnostic (CESM with DBT) |
| Digital Tomosynthesis MammographyAlso: DBT, Digital Breast Tomosynthesis, Digital Tomosynthesis of the BreastUndergo CESM with DBT | Procedure or surgery | Diagnostic (CESM with DBT) |
| Dual-Energy Contrast-Enhanced Digital Spectral MammographyAlso: Dual-Energy Contrast-Enhanced Digital Mammography (CEDM), Dual-Energy Contrast-Enhanced Digital Subtraction MammographyUndergo CESM with DBT | Procedure or surgery | Diagnostic (CESM with DBT) |
Primary outcome
Index lesion size using the largest diameter
Time frame: Baseline
Intra-class correlation will be used to assess the agreement of index lesion size from each imaging reading to the gold standard (histopathology at surgery). Bland-Altman plot will be used to illustrate the pattern of difference between each reading and the gold standard.
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 18 Nov 2021.
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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.
Mary Yamashita, MD principal investigator
University of Southern California
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 Agent, Digital Tomosynthesis Mammography and Dual-Energy Contrast-Enhanced Digital Spectral Mammography in people with Breast Carcinoma, run by University of Southern California 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 1 inclusion and 6 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 18 Nov 2021. 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?
Index lesion size using the largest diameter (time frame: Baseline). 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 18 Nov 2021.