Back to resultsInitial Evaluation of Ultra FAST Breast Magnetic Resonance in Breast Cancer Screening: Comparative Study With Mammography and Ultrasound.
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MRI screening
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring screening, MRI
Eligibility Criteria
Inclusion Criteria:
- Women referred for routine breast cancer screening
Exclusion Criteria:
- Disabled women (eg, unable to stand)
- Pregnant women
- Allergy to Gadolinium
Sites / Locations
- CHU Brugmann
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI screening
Arm Description
Diagnostic screening. The normal eligible screening population will first undergo a mammography, then an echography screening followed by a fast MRI screening.
Outcomes
Primary Outcome Measures
ACR five point rating scale for mammography images
Two views (craniocaudal and mediolateral oblique) will be obtained of each breast with digital mammography by using a commercially available system. The reader will first interpret the digital mammography using a dedicated workstation.The radiologist will rate the images from each examination by using a standardized ACR five-point rating scale. Furthermore, if a reader records a positive score (>2), mammographic features have to be specified (localization, number of ACR>2 lesions,using predefined evaluation form). Scores are recorded directly into the PACS database and locked after each reading session.
ACR five point rating scale for echography images
After the digital mammography, the same reader will perform Ultrasound of both breasts using the transmitter of 10-13 MHertz (Acuson Antares (Siemens)). The reader will then interpret the ultrasound images using the same methodology as for digital mammography, described above (ACR five point rating scale).
ACR five point rating scale for MRI imaging
The same day, the Ultra FAST Breast Magnetic Resonance will be performed on 3T unit with 8 channel dedicated breast coil. Sequences: 3 Dimensional Gradient echo with Fat Saturation before and after Gadolinium injection (acquisition time 2 minutes). Initial post processing: MPR and automatic subtraction. The reader has to assess the MRI images using the same methodology as for digital mammography, according to the American College of Radiology Breast Imaging Reporting and Data System.
Secondary Outcome Measures
Full Information
NCT ID
NCT02324894
First Posted
December 19, 2014
Last Updated
April 16, 2019
Sponsor
Brugmann University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02324894
Brief Title
Initial Evaluation of Ultra FAST Breast Magnetic Resonance in Breast Cancer Screening: Comparative Study With Mammography and Ultrasound.
Official Title
Initial Evaluation of Ultra FAST Breast Magnetic Resonance in Breast Cancer Screening: Comparative Study With Mammography and Ultrasound.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Was never initiated.
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
April 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mammography remains an imperfect screening test especially in women with extremely dense breast tissue, missing biologically aggressive cancers especially in younger population and picking up indolent cancers that do not need treatment.
The most sensitive test for breast cancer detection at our disposal is magnetic resonance imaging (MRI). The preliminary study of Dr Kuhl provide strong arguments that Ultra FAST Breast Magnetic Resonance is suitable for breast cancer screening with high sensitivity and specificity values.
Data clearly demonstrates that FAST breast MRI could be the standard for breast cancer screening: it is safe, does not induce cancers, and can find more cancers than mammography.
However this study was performed in women with low to moderately increased risk.The value of FAST Breast Magnetic Resonance in normal screening population has to be assessed before a modification of current strategy of breast cancer screening with mammography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
screening, MRI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI screening
Arm Type
Other
Arm Description
Diagnostic screening. The normal eligible screening population will first undergo a mammography, then an echography screening followed by a fast MRI screening.
Intervention Type
Procedure
Intervention Name(s)
MRI screening
Intervention Description
Diagnostic screening. The normal eligible screening population will first undergo a mammography, then an echography screening followed by a fast MRI screening.
Primary Outcome Measure Information:
Title
ACR five point rating scale for mammography images
Description
Two views (craniocaudal and mediolateral oblique) will be obtained of each breast with digital mammography by using a commercially available system. The reader will first interpret the digital mammography using a dedicated workstation.The radiologist will rate the images from each examination by using a standardized ACR five-point rating scale. Furthermore, if a reader records a positive score (>2), mammographic features have to be specified (localization, number of ACR>2 lesions,using predefined evaluation form). Scores are recorded directly into the PACS database and locked after each reading session.
Time Frame
24h
Title
ACR five point rating scale for echography images
Description
After the digital mammography, the same reader will perform Ultrasound of both breasts using the transmitter of 10-13 MHertz (Acuson Antares (Siemens)). The reader will then interpret the ultrasound images using the same methodology as for digital mammography, described above (ACR five point rating scale).
Time Frame
24h
Title
ACR five point rating scale for MRI imaging
Description
The same day, the Ultra FAST Breast Magnetic Resonance will be performed on 3T unit with 8 channel dedicated breast coil. Sequences: 3 Dimensional Gradient echo with Fat Saturation before and after Gadolinium injection (acquisition time 2 minutes). Initial post processing: MPR and automatic subtraction. The reader has to assess the MRI images using the same methodology as for digital mammography, according to the American College of Radiology Breast Imaging Reporting and Data System.
Time Frame
24h
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women referred for routine breast cancer screening
Exclusion Criteria:
Disabled women (eg, unable to stand)
Pregnant women
Allergy to Gadolinium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tadeusz Stadnik, MD, PhD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
21712474
Citation
Tabar L, Vitak B, Chen TH, Yen AM, Cohen A, Tot T, Chiu SY, Chen SL, Fann JC, Rosell J, Fohlin H, Smith RA, Duffy SW. Swedish two-county trial: impact of mammographic screening on breast cancer mortality during 3 decades. Radiology. 2011 Sep;260(3):658-63. doi: 10.1148/radiol.11110469. Epub 2011 Jun 28.
Results Reference
background
PubMed Identifier
24536051
Citation
Kopans DB. Arguments against mammography screening continue to be based on faulty science. Oncologist. 2014 Feb;19(2):107-12. doi: 10.1634/theoncologist.2013-0184.
Results Reference
background
PubMed Identifier
24519768
Citation
Miller AB, Wall C, Baines CJ, Sun P, To T, Narod SA. Twenty five year follow-up for breast cancer incidence and mortality of the Canadian National Breast Screening Study: randomised screening trial. BMJ. 2014 Feb 11;348:g366. doi: 10.1136/bmj.g366.
Results Reference
background
PubMed Identifier
24738641
Citation
Biller-Andorno N, Juni P. Abolishing mammography screening programs? A view from the Swiss Medical Board. N Engl J Med. 2014 May 22;370(21):1965-7. doi: 10.1056/NEJMp1401875. Epub 2014 Apr 16. No abstract available.
Results Reference
background
PubMed Identifier
19962093
Citation
Morris EA. Diagnostic breast MR imaging: current status and future directions. Magn Reson Imaging Clin N Am. 2010 Feb;18(1):57-74. doi: 10.1016/j.mric.2009.09.005.
Results Reference
background
PubMed Identifier
24958821
Citation
Kuhl CK, Schrading S, Strobel K, Schild HH, Hilgers RD, Bieling HB. Abbreviated breast magnetic resonance imaging (MRI): first postcontrast subtracted images and maximum-intensity projection-a novel approach to breast cancer screening with MRI. J Clin Oncol. 2014 Aug 1;32(22):2304-10. doi: 10.1200/JCO.2013.52.5386. Epub 2014 Jun 23.
Results Reference
background
PubMed Identifier
22474203
Citation
Berg WA, Zhang Z, Lehrer D, Jong RA, Pisano ED, Barr RG, Bohm-Velez M, Mahoney MC, Evans WP 3rd, Larsen LH, Morton MJ, Mendelson EB, Farria DM, Cormack JB, Marques HS, Adams A, Yeh NM, Gabrielli G; ACRIN 6666 Investigators. Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk. JAMA. 2012 Apr 4;307(13):1394-404. doi: 10.1001/jama.2012.388.
Results Reference
background
PubMed Identifier
18477782
Citation
Berg WA, Blume JD, Cormack JB, Mendelson EB, Lehrer D, Bohm-Velez M, Pisano ED, Jong RA, Evans WP, Morton MJ, Mahoney MC, Larsen LH, Barr RG, Farria DM, Marques HS, Boparai K; ACRIN 6666 Investigators. Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA. 2008 May 14;299(18):2151-63. doi: 10.1001/jama.299.18.2151. Erratum In: JAMA. 2010 Apr 21;303(15):1482.
Results Reference
background
PubMed Identifier
20177029
Citation
Kuhl C, Weigel S, Schrading S, Arand B, Bieling H, Konig R, Tombach B, Leutner C, Rieber-Brambs A, Nordhoff D, Heindel W, Reiser M, Schild HH. Prospective multicenter cohort study to refine management recommendations for women at elevated familial risk of breast cancer: the EVA trial. J Clin Oncol. 2010 Mar 20;28(9):1450-7. doi: 10.1200/JCO.2009.23.0839. Epub 2010 Feb 22.
Results Reference
background
PubMed Identifier
19864520
Citation
Kuhl CK. Why do purely intraductal cancers enhance on breast MR images? Radiology. 2009 Nov;253(2):281-3. doi: 10.1148/radiol.2532091401. No abstract available.
Results Reference
background
PubMed Identifier
20868891
Citation
Feig S. Cost-effectiveness of mammography, MRI, and ultrasonography for breast cancer screening. Radiol Clin North Am. 2010 Sep;48(5):879-91. doi: 10.1016/j.rcl.2010.06.002.
Results Reference
background
Learn more about this trial
Initial Evaluation of Ultra FAST Breast Magnetic Resonance in Breast Cancer Screening: Comparative Study With Mammography and Ultrasound.
We'll reach out to this number within 24 hrs