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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02826369
Other study ID # 2015-A00581-48
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2016
Est. completion date April 12, 2016

Study information

Verified date August 2018
Source Institut de Cancérologie de Lorraine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date April 12, 2016
Est. primary completion date April 12, 2016
Accepts healthy volunteers No
Gender Female
Age group N/A to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
France Institut de Cancérologie de Lorraine Vandoeuvre-Lès -Nancy

Sponsors (1)

Lead Sponsor Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Agreement between compressed sensing and standard image acquisition Agreement between compressed sensing and standard image acquisition is defined by percentage of lesions detected by both modes of acquisitions 1 day
Secondary Analysis of dammage contours Analysis of lesions contours will be performed according to Bi-RADS classification 1 day
Secondary Image quality in compressed sensing acquisition The image quality will be evaluated using a quality scale 1 day
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