NCT02826369

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

14 days

First QC Date

July 5, 2016

Last Update Submit

August 7, 2018

Conditions

Keywords

AlgorithmsImage Processing, Computer-Assisted/methods*Magnetic Resonance Imaging/methods*Data CompressionBreast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Analysis of dammage contours

    1 day

  • Image quality in compressed sensing acquisition

    1 day

Study Arms (1)

3.0 Tesla in Magnetic Resonance Imaging

EXPERIMENTAL
Other: 3.0 Tesla in Magnetic Resonance Imaging

Interventions

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.

3.0 Tesla in Magnetic Resonance Imaging

Eligibility Criteria

AgeUp to 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years old
  • Claustrophobia
  • Contraindication to the injection of gadolinium contrast medium
  • Contraindication to MRI
  • Persons deprived of liberty or under supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • OLDRINI Guillaume, MD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 11, 2016

Study Start

March 29, 2016

Primary Completion

April 12, 2016

Study Completion

April 12, 2016

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations