Ductal Breast Carcinoma In SituNCT02587663
Extent of Breast Cancer and the Role of Pre-Operative Sonography and MRI
A study testing Contrast-enhanced Magnetic Resonance Imaging, Mammography and Therapeutic Conventional Surgery in people with Ductal Breast Carcinoma In Situ and Stage IA Breast Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This clinical trial studies mammography and targeted ultrasound with or without whole-breast ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent of disease before surgery in patients with newly diagnosed breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma In Situ, Stage IA Breast Cancer, Stage IB Breast Cancer
- What is being tested?
- Contrast-enhanced Magnetic Resonance Imaging, Mammography and Therapeutic Conventional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2005to 20 Nov 2012
- 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
- Competent to provide informed consent
- Pathologically proven invasive breast cancer or ductal carcinoma in situ (DCIS) originally identified clinically or mammographically and diagnosed by percutaneous core biopsy
- Eligible for breast conserving surgery followed by radiation therapy
Who cannot join
- Women with surgical excisional biopsy that diagnosed the breast cancer
- Women with clinical or mammographic findings where breast conserving surgery is not an option
- Women that clinically or mammographically have breast cancers that are fixed to skin
- Women receiving neoadjuvant chemotherapy prior to surgery
- Women having contraindications to contrast-enhanced (CE)-MRI examination (e.g., claustrophobia and allergy to gadolinium)
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: Sonography Compared With MRI in Pre-Operative Evaluation of Patients With Breast Cancer to Determine Extent of Breast Disease
This clinical trial studies mammography and targeted ultrasound with or without whole-breast ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent of disease before surgery in patients with newly diagnosed breast cancer. New diagnostic imaging procedures, such as whole-breast ultrasound or contrast-enhanced MRI, may help find out how far breast cancer has spread. It is not yet known whether mammography and targeted ultrasound are more effective with or without whole-breast ultrasound or contrast-enhanced MRI in finding out how far breast cancer has spread.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine how surgical treatment is influenced by the three imaging arms.
II. To compare three imaging arms in terms of accurately measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as gold standard).
SECONDARY OBJECTIVES:
- In women with dense breasts: To retrospectively compare the accuracy of three imaging arms in measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as the gold standard).
II. To report the incidence of synchronous contralateral breast cancers detected by the three imaging arms.
OUTLINE: Patients are assigned to 1 of 3 treatment groups.
GROUP 1: Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.
GROUP 2: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.
GROUP 3: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
All patients undergo standard of care breast conserving surgery, or mastectomy if the tests indicate a change in the surgical plan.
- Conditions
- Ductal Breast Carcinoma In Situ, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Being tested
- Contrast-enhanced Magnetic Resonance Imaging, Mammography, Therapeutic Conventional Surgery, Ultrasonography, Gadolinium
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced Magnetic Resonance ImagingProcedure or surgery
Also called CONTRAST ENHANCED MRI, Contrast-enhanced MRI
Undergo bilateral breast contrast enhanced MRI
MammographyProcedure or surgery
Undergo bilateral mammography
Therapeutic Conventional SurgeryProcedure or surgery
Undergo breast conserving surgery
UltrasonographyProcedure or surgery
Also called ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical
Undergo bilateral whole-breast ultrasound
UltrasonographyProcedure or surgery
Also called ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical
Undergo targeted breast ultrasound
GadoliniumOther
Also called GBCA
Contrast agent used in MRI
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (standard of care) | Active comparator | Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound. Receives: Procedure: Mammography; Procedure: Therapeutic Conventional Surgery; Procedure: Ultrasonography |
| Group 2 (bilateral whole-breast ultrasound) | Experimental | Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound. Receives: Procedure: Mammography; Procedure: Therapeutic Conventional Surgery; Procedure: Ultrasonography |
| Group 3 (bilateral breast contrast-enhanced MRI) | Experimental | Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI. Receives: Procedure: Contrast-enhanced Magnetic Resonance Imaging; Procedure: Mammography; Procedure: Therapeutic Conventional Surgery; Procedure: Ultrasonography; Other: Gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the longest diameter of the index lesion as determined by imaging versus as determined by the pathologist
Every attempt will be made to identify a transformation for the difference in the lengths of the largest diameters. If none are found, then the data will be summarized with histograms, medians, quartiles, and ranges. If a transformation is found, means, standard deviations, and 95% confidence intervals will be reported instead of the median and quartiles. Differences between three imaging methods will be compared using a paired t-test (or paired rank sum test).
Measured: Up to 4 weeks
Secondary outcomes (1)
Number of patients identified with invasive breast cancer in women who have dense or no dense breasts as determined by the 3 imaging arms
The analyses above will be rerun, stratifying by breast density: the differences in the modalities will be estimated for women with dense breasts and without, and the differences between the two groups of women will also be estimated. Dense will be defined as dense parenchyma involving more than 50% of breast volume.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start20 Nov 2005
- Primary completion20 Nov 2011
- Study completion20 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Breast Carcinoma In SituStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 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
- Linda Hovanessian-Larsen, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587663
- Sponsor's protocol ID
- 1B-05-5
- Other IDs
- NCI-2011-01365, 1B-05-5, P30CA014089
- Status last verified
- May 2019
- First submitted
- 13 Sep 2015
- Last updated
- 16 May 2019
- 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 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonography Compared With MRI in Pre-Operative Evaluation of Patients With Breast Cancer to Determine Extent of Breast Disease
- ClinicalTrials.gov ID
- NCT02587663
- Acronym / sponsor ID
- 1B-05-5
- Conditions
- Ductal Breast Carcinoma In Situ, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Nov 2005 (actual)
- Primary completion
- 20 Nov 2011 (actual)
- Study completion
- 20 Nov 2012 (actual)
- First posted
- 27 Oct 2015 (estimated)
- 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 clinical trial studies mammography and targeted ultrasound with or without whole-breast ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent of disease before surgery in patients with newly diagnosed breast cancer. New diagnostic imaging procedures, such as whole-breast ultrasound or contrast-enhanced MRI, may help find out how far breast cancer has spread. It is not yet known whether mammography and targeted ultrasound are more effective with or without whole-breast ultrasound or contrast-enhanced MRI in finding out how far breast cancer has spread.
Detailed description
PRIMARY OBJECTIVES:
- To determine how surgical treatment is influenced by the three imaging arms.
II. To compare three imaging arms in terms of accurately measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as gold standard).
SECONDARY OBJECTIVES:
- In women with dense breasts: To retrospectively compare the accuracy of three imaging arms in measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as the gold standard).
II. To report the incidence of synchronous contralateral breast cancers detected by the three imaging arms.
OUTLINE: Patients are assigned to 1 of 3 treatment groups.
GROUP 1: Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.
GROUP 2: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.
GROUP 3: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
All patients undergo standard of care breast conserving surgery, or mastectomy if the tests indicate a change in the surgical plan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (standard of care) | Active comparator | Procedure: Mammography, Procedure: Therapeutic Conventional Surgery, Procedure: UltrasonographyPatients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound. |
| Group 2 (bilateral whole-breast ultrasound) | Experimental | Procedure: Mammography, Procedure: Therapeutic Conventional Surgery, Procedure: UltrasonographyPatients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound. |
| Group 3 (bilateral breast contrast-enhanced MRI) | Experimental | Procedure: Contrast-enhanced Magnetic Resonance Imaging, Procedure: Mammography, Procedure: Therapeutic Conventional Surgery, Procedure: Ultrasonography, Other: GadoliniumPatients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI. |
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)
- Competent to provide informed consent
- Pathologically proven invasive breast cancer or ductal carcinoma in situ (DCIS) originally identified clinically or mammographically and diagnosed by percutaneous core biopsy
- Eligible for breast conserving surgery followed by radiation therapy
Key exclusion criteria (5 listed)
- Women with surgical excisional biopsy that diagnosed the breast cancer
- Women with clinical or mammographic findings where breast conserving surgery is not an option
- Women that clinically or mammographically have breast cancers that are fixed to skin
- Women receiving neoadjuvant chemotherapy prior to surgery
- Women having contraindications to contrast-enhanced (CE)-MRI examination (e.g., claustrophobia and allergy to gadolinium)
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 Magnetic Resonance ImagingAlso: CONTRAST ENHANCED MRI, Contrast-enhanced MRIUndergo bilateral breast contrast enhanced MRI | Procedure or surgery | Group 3 (bilateral breast contrast-enhanced MRI) |
| MammographyUndergo bilateral mammography | Procedure or surgery | Group 1 (standard of care), Group 2 (bilateral whole-breast ultrasound), Group 3 (bilateral breast contrast-enhanced MRI) |
| Therapeutic Conventional SurgeryUndergo breast conserving surgery | Procedure or surgery | Group 1 (standard of care), Group 2 (bilateral whole-breast ultrasound), Group 3 (bilateral breast contrast-enhanced MRI) |
| UltrasonographyAlso: ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, MedicalUndergo bilateral whole-breast ultrasound | Procedure or surgery | Group 2 (bilateral whole-breast ultrasound) |
| UltrasonographyAlso: ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, MedicalUndergo targeted breast ultrasound | Procedure or surgery | Group 1 (standard of care), Group 2 (bilateral whole-breast ultrasound), Group 3 (bilateral breast contrast-enhanced MRI) |
| GadoliniumAlso: GBCAContrast agent used in MRI | Other | Group 3 (bilateral breast contrast-enhanced MRI) |
Primary outcome
Difference between the longest diameter of the index lesion as determined by imaging versus as determined by the pathologist
Time frame: Up to 4 weeks
Every attempt will be made to identify a transformation for the difference in the lengths of the largest diameters. If none are found, then the data will be summarized with histograms, medians, quartiles, and ranges. If a transformation is found, means, standard deviations, and 95% confidence intervals will be reported instead of the median and quartiles. Differences between three imaging methods will be compared using a paired t-test (or paired rank sum test).
1 secondary outcome
Number of patients identified with invasive breast cancer in women who have dense or no dense breasts as determined by the 3 imaging arms
Time frame: Up to 4 weeks
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 16 May 2019.
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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.
Linda Hovanessian-Larsen 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-enhanced Magnetic Resonance Imaging, Mammography and Therapeutic Conventional Surgery in people with Ductal Breast Carcinoma In Situ and Stage IA Breast Cancer, 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 3 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: finished, as of the sponsor's last update on 16 May 2019. 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?
Difference between the longest diameter of the index lesion as determined by imaging versus as determined by the pathologist (time frame: Up to 4 weeks). 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 16 May 2019.