- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826369
Use of Compressed Sensing in Breast MRI (COMPRIM)
Breast MRI is increasingly important in breast screening imaging. It is currently based on dynamic sequences after contrast injection whose temporal resolution must be less than 90 seconds with dynamic acquisitions at different times.
These curves profiles are designed to differentiate benign from malignant lesions. Recently, Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions; lesion enhancement curves over time were more accurate than the curves usually performed.
It seems necessary to work on sequences having better temporal resolution without compromising however spatial resolution.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vandoeuvre-Lès -Nancy, France, 54500
- Institut de Cancerologie de Lorraine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient to benefit a MRI in the assessment for a breast carcinoma
- Age >18 years old
- Assessment on 3.0 Tesla in Magnetic Resonance Imaging
- ECOG performance status ≤ 3
- Ability to provide an informed written consent form
Exclusion Criteria:
- Age < 18 years old
- Claustrophobia
- Contraindication to the injection of gadolinium contrast medium
- Contraindication to MRI
- Persons deprived of liberty or under supervision
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 3.0 Tesla in Magnetic Resonance Imaging
|
Eligible patient will have a standard MRI. The images taken before 4min30 and after 6min after to the injection of gadolimium contrast medium will be carried out with the standard image acquisition. The images taken between 4min30 and 6min after the injection of gadolimium contrast medium will be carried out with the compressed sensing image acquisition. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Agreement between compressed sensing and standard image acquisition
Time Frame: 1 day
|
Agreement between compressed sensing and standard image acquisition is defined by percentage of lesions detected by both modes of acquisitions
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis of dammage contours
Time Frame: 1 day
|
Analysis of lesions contours will be performed according to Bi-RADS classification
|
1 day
|
|
Image quality in compressed sensing acquisition
Time Frame: 1 day
|
The image quality will be evaluated using a quality scale
|
1 day
|
Collaborators and Investigators
Investigators
- Principal Investigator: OLDRINI Guillaume, MD, Institut de Cancerologie de Lorraine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2015-A00581-48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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