Study Stopped
Delayed start due to technical problems as well as the covid pandemic. Decision of the investigator
Advanced MR Techniques for Breast Cancer Detection
RAPIDIRM
Evaluation of Advanced MRI Acquisition Techniques for Perfusion and Diffusion to Detect Breast Cancer
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
Evaluation of advanced MRI acquisition techniques (perfusion and diffusion) to detect breast cancer. Two MR advanced sequences will be added to a standard breast MRI protocol for evaluation purpose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2019
Longer than P75 for not_applicable breast-cancer
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
First Submitted
Initial submission to the registry
May 24, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedOctober 20, 2021
October 1, 2021
3.3 years
May 24, 2019
October 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mammary lesions Visualization on ultrafast injected dynamic MRI: Yes/No
to evaluate whether ultrafast injected dynamic breast MRI, coupled or not with a diffusion sequence, allows to improve the specificity of standard MRI while maintaining the same sensitivity
Day 1 at inclusion
Mammary lesions Visualization with a diffusion sequence
to evaluate whether ultrafast injected dynamic breast MRI, coupled or not with a diffusion sequence, allows to improve the specificity of standard MRI while maintaining the same sensitivity
Day 1 at inclusion
Secondary Outcomes (7)
Quantitative perfusion parameters : Enhancement Integral (EI (%))
Day 1 at inclusion
Quantitative perfusion parameters : Maximum Slope of Increase (MSI (%/sec))
Day 1 at inclusion
Quantitative perfusion parameters : Maximum of enhancement (Rmax (%))
Day 1 at inclusion
Quantitative perfusion parameters : Timing of Maximum of enhancement (RmaxTiming (sec))
Day 1 at inclusion
Quantitative perfusion parameters : Wash-inrate (WIR (%/sec)
Day 1 at inclusion
- +2 more secondary outcomes
Study Arms (1)
Patient with an injected breast MR exam
EXPERIMENTALInterventions
The MR sequences added to the protocol are dedicated sequences for perfusion and diffusion imaging of breast lesion.
Eligibility Criteria
You may qualify if:
- Adult patient
- Patient who has signed a consent form to participate in the study
- Affiliated patient or beneficiary of a social security scheme
- Patient with an injected breast MR exam planned as part of her care pathway.
You may not qualify if:
- Patients under guardianship or curatorship
- Pregnant or breastfeeding patients
- Patients with contraindications to realization of an MR exam and an injected MR exam
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- GE Healthcarecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle THOMASSIN-NAGGARA, PU-PH
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2019
First Posted
July 16, 2019
Study Start
July 1, 2019
Primary Completion
November 1, 2022
Study Completion
July 1, 2024
Last Updated
October 20, 2021
Record last verified: 2021-10