Breast NeoplasmsBCDNCT02411760
Investigation of Diagnostic Improvement Gained Through Optimization of MR Methods for Breast Cancer Detection
An observational study of Breast Neoplasms, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
In a single MRI exam on a research scanner, each lesion will be categorized using the BI-RADS MRI score, which utilizes the DCE data alone, and then again using a modified BI-RADS score, which utilizes both DWI and DCE data. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- 3 Tesla Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2017
- Phase
- Observational
- 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
Study population: Patients from the UTSW Breast Imaging Center referred for breast biopsy due to suspicious mammography or ultrasound exams (SOC) with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5.
Who may be able to join
- Women with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5 Age ≥ 18 years Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Subjects who have had a needle biopsy of the suspicious area within the last 6 weeks Subjects who have contraindication to contrast enhanced MRI examination.
- Contraindications to MRI examinations include:
- Medically unstable
- Heart failure
- Unstable angina
- Child bearing
Show all 15Show fewer
- Lactating Any contraindication per MRI Screening Form (Appendix A attached).
- Implants contraindicated at 3T, pacemakers
- Poorly controlled diabetes
- Body weight greater than 300 pounds
- Claustrophobic Since each patient is receiving a gadolinium based contrast agent intravenously:
- eGFR < 60 mL/min/1.73m2
- Sickle cell disease
- Hemolytic anemia
- Subjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center - Advanced Imaging Research Center
Dallas, Texas, 75390
About this study
In a single MRI exam on a research scanner, each lesion will be categorized using the BI-RADS MRI score, which utilizes the DCE data alone, and then again using a modified BI-RADS score, which utilizes both DWI and DCE data. The sensitivity and specificity of each approach will be determined using pathology as the gold standard.
Read the detailed description
MR examinations will be performed on a 3.0 Tesla GE whole-body scanner using an elliptically driven body coil for transmit and a multi-channel bilateral breast coil for receive. The multi-channel coil will consist of 8, 16 or 31 channels. DCE-MRI: DCE-MRI will be carried out using a three-dimensional (3D) turbo fast lowangle gradient echo sequence (TFE) combined with parallel acquisition Sensitivity Encoding (SENSE) technique. The imaging plane will be set in axial plane so that both breasts are included in the images. One image will be acquired before and four images will be acquired after intravenous administration of a standard dose of 0.1 mmol per kg of body weight of Gadavist (Schering AG, Germany) at a rate of 3ml/sec. with subjects in the prone position, breathing normally during the scan. The total scan time for the DCEMRI will be about 8 minutes.
Pharmacokinetic parameters, including the volume transfer constant Ktrans, the fractional volume of extravascular extracellular space of the target tissue ve, and the rate constant kep, will be estimated by fitting a pharmacokinetic model to the time-intensity curves obtained from the DCE-MRI. In this study, the concentration of tracer Ct(t) after bolus injection is assumed to obey the model proposed by Tofts and Kermode (20). DWI-MRI examinations: The DWI acquisition will occur before and/or after contrast enhancement used in DCE imaging. Immediately after the completion of imaging with the 16 (or 31) channel breast coil, the patient will be repositioned replacing the breast coil with an 8 channel breast coil and additional DWI acquisitions will be made. Data for apparent diffusion coefficient assessment on diffusion-weighted imaging will be acquired using a single-shot Echo Planar Imaging sequence in the transverse plane. The DWI protocol will acquire images with up to 16 different b values. Slice dependent shimming will be performed to provide the maximum B0 homogeneity for each slice. The total scan time for the DWI-MRI will be about 5 minutes.
All of the DWI image data from the MRI examinations will be stored on a dedicated HIPPA compliant computer workstation (located in room NE6.114) for analysis. The relevant parameters will be mean ADC and the histogram of ADC in the lesions.
Conductivity imaging: A B1 map and a spin echo image will be acquired for measuring tissue conductivity (21).
The images used for conductivity measurement will be anonymized and sent to the manufacturer for further development of post-processing techniques.
- Conditions
- Breast Neoplasms
- Being tested
- 3 Tesla Magnetic Resonance Imaging
- Keywords
- MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Tesla Magnetic Resonance ImagingProcedure or surgery
Also called Diffusion Weighted Imaging, Dynamic Contrast Enhanced
Assessment of the performance of DWI/ADC measurements alone, and as an adjunct to dynamic contrast enhanced (DCE) MRI in diagnosing/characterizing breast cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Improvement Gained using an optimized MR Method for Breast Cancer Detection.
The sensitivity and specificity of breast cancer detection using ADC maps acquired with a 31 channel breast coil and improved B0 shimming will be compared to the sensitivity and specificity of cancer detection using DCE MRI.
Measured: Each of 60 patients will have 1 60 minute scan prior to biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2017
- Study completionMay 2017
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 University of Texas Southwestern Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Lenkinski, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411760
- Sponsor's protocol ID
- STU 052014-042
- Acronym
- BCD
- Status last verified
- Oct 2017
- First submitted
- 27 Feb 2015
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Diagnostic Improvement Gained Through Optimization of MR Methods for Breast Cancer Detection
- ClinicalTrials.gov ID
- NCT02411760
- Acronym / sponsor ID
- BCD / STU 052014-042
- Conditions
- Breast Neoplasms
- Keywords
- MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 8 Apr 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.
In a single MRI exam on a research scanner, each lesion will be categorized using the BI-RADS MRI score, which utilizes the DCE data alone, and then again using a modified BI-RADS score, which utilizes both DWI and DCE data. The sensitivity and specificity of each approach will be determined using pathology as the gold standard.
Detailed description
MR examinations will be performed on a 3.0 Tesla GE whole-body scanner using an elliptically driven body coil for transmit and a multi-channel bilateral breast coil for receive. The multi-channel coil will consist of 8, 16 or 31 channels. DCE-MRI: DCE-MRI will be carried out using a three-dimensional (3D) turbo fast lowangle gradient echo sequence (TFE) combined with parallel acquisition Sensitivity Encoding (SENSE) technique. The imaging plane will be set in axial plane so that both breasts are included in the images. One image will be acquired before and four images will be acquired after intravenous administration of a standard dose of 0.1 mmol per kg of body weight of Gadavist (Schering AG, Germany) at a rate of 3ml/sec. with subjects in the prone position, breathing normally during the scan. The total scan time for the DCEMRI will be about 8 minutes.
Pharmacokinetic parameters, including the volume transfer constant Ktrans, the fractional volume of extravascular extracellular space of the target tissue ve, and the rate constant kep, will be estimated by fitting a pharmacokinetic model to the time-intensity curves obtained from the DCE-MRI. In this study, the concentration of tracer Ct(t) after bolus injection is assumed to obey the model proposed by Tofts and Kermode (20). DWI-MRI examinations: The DWI acquisition will occur before and/or after contrast enhancement used in DCE imaging. Immediately after the completion of imaging with the 16 (or 31) channel breast coil, the patient will be repositioned replacing the breast coil with an 8 channel breast coil and additional DWI acquisitions will be made. Data for apparent diffusion coefficient assessment on diffusion-weighted imaging will be acquired using a single-shot Echo Planar Imaging sequence in the transverse plane. The DWI protocol will acquire images with up to 16 different b values. Slice dependent shimming will be performed to provide the maximum B0 homogeneity for each slice. The total scan time for the DWI-MRI will be about 5 minutes.
All of the DWI image data from the MRI examinations will be stored on a dedicated HIPPA compliant computer workstation (located in room NE6.114) for analysis. The relevant parameters will be mean ADC and the histogram of ADC in the lesions.
Conductivity imaging: A B1 map and a spin echo image will be acquired for measuring tissue conductivity (21).
The images used for conductivity measurement will be anonymized and sent to the manufacturer for further development of post-processing techniques.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the UTSW Breast Imaging Center referred for breast biopsy due to suspicious mammography or ultrasound exams (SOC) with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5.
Key inclusion criteria (1 listed)
- Women with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5 Age ≥ 18 years Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (15 listed)
- Subjects who have had a needle biopsy of the suspicious area within the last 6 weeks Subjects who have contraindication to contrast enhanced MRI examination.
- Medically unstable
- Heart failure
- Unstable angina
- Child bearing
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 |
|---|---|---|
| 3 Tesla Magnetic Resonance ImagingAlso: Diffusion Weighted Imaging, Dynamic Contrast EnhancedAssessment of the performance of DWI/ADC measurements alone, and as an adjunct to dynamic contrast enhanced (DCE) MRI in diagnosing/characterizing breast cancer. | Procedure or surgery | – |
Primary outcome
Diagnostic Improvement Gained using an optimized MR Method for Breast Cancer Detection.
Time frame: Each of 60 patients will have 1 60 minute scan prior to biopsy
The sensitivity and specificity of breast cancer detection using ADC maps acquired with a 31 channel breast coil and improved B0 shimming will be compared to the sensitivity and specificity of cancer detection using DCE MRI.
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 19 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Robert Lenkinski, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by University of Texas Southwestern Medical Center 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 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: finished, as of the sponsor's last update on 19 Oct 2017. 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?
Diagnostic Improvement Gained using an optimized MR Method for Breast Cancer Detection. (time frame: Each of 60 patients will have 1 60 minute scan prior to biopsy). 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 19 Oct 2017.