Breast CancerRAPIDIRMNCT04020523
Advanced MR Techniques for Breast Cancer Detection
A study testing MRI sequence in people with Breast Cancer, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2019to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients under guardianship or curatorship
- Pregnant or breastfeeding patients
- Patients with contraindications to realization of an MR exam and an injected MR exam
About this study
Official title: Evaluation of Advanced MRI Acquisition Techniques for Perfusion and Diffusion to Detect Breast Cancer
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.
Read the detailed description
This is a prospective monocentric longitudinal study on a consecutive population of patients who require breast MRI as part of their course of care in the radiology department of the Tenon Hospital (3T MRI).
The standard protocol for breast MRI routinely performed in Tenon hospital consists of a set of MR acquisitions performed with contrast agent injection. The research consists of adding perfusion and diffusion sequences to the regular MR protocol. The addition of these sequences does not require a new injection of contrast medium.
Diagnosis of lesions after the breast MR exam will be performed using standard MR sequences as usual. According to the recommendations of SIFEM, the final diagnosis of the lesions will be made either by histological analysis of a biopsy performed as part of the patient's standard care pathway, or during patient's follow-up if a biopsy is not indicated (up to two years after breast MR exam).
The research will focus on evaluating the sensitivity and specificity of perfusion MRI sequence with or without diffusion MRI sequence compared to the sensitivity and specificity of the standard protocol.
For the perfusion sequence, the following data will be extracted: qualitative (shape of the contrast curve), semi-quantitative (elevation slope and asymptote of the curve) and quantitative by compartmental modeling (tissue perfusion, blood volume fraction, surface capillary permeability).
For the diffusion MRI, the extraction of quantitative data such as CDA, IVIM and Kurtosis will be performed and parametric maps, cellularity maps and an assessment of lesion heterogeneity will be calculated.
A correlation will be made with histological, immunohistochemical and molecular results of cancers following biopsy
- Conditions
- Breast Cancer
- Being tested
- MRI sequence
- Keywords
- MRI, breast, cancer, screening, innovative sequences
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI sequenceOther
The MR sequences added to the protocol are dedicated sequences for perfusion and diffusion imaging of breast lesion.
| Study group | Role | What they receive |
|---|---|---|
| Patient with an injected breast MR exam | Experimental | Not described Receives: Other: MRI sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 1 at inclusion
Secondary outcomes (7)
Quantitative perfusion parameters : Enhancement Integral (EI (%))
Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
Measured: Day 1 at inclusion
Quantitative perfusion parameters : Maximum Slope of Increase (MSI (%/sec))
Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
Measured: Day 1 at inclusion
Quantitative perfusion parameters : Maximum of enhancement (Rmax (%))
Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
Measured: Day 1 at inclusion
Quantitative perfusion parameters : Timing of Maximum of enhancement (RmaxTiming (sec))
Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
Measured: Day 1 at inclusion
Quantitative perfusion parameters : Wash-inrate (WIR (%/sec)
Correlate the parameters of perfusion MR sequence with the markers immunochemicals of tumor angiogenesis on anatomopathological specimen
Measured: Day 1 at inclusion
Correlate diffusion MRI parameters with immunochemical markers of tumor angiogenesis on anatomopathological specimen Quantitative diffusion parameter : Apparent Coefficient Diffusion
Measured: Day 1 at inclusion
Evaluate the reduction in the time required to acquire and interpret the new breast MR protocol compared to the standard one
Measured: Day 1 at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study startJul 2019 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionJul 2024 (estimated)
Why it stopped: Delayed start due to technical problems as well as the covid pandemic. Decision of the investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Isabelle THOMASSIN-NAGGARA, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020523
- Sponsor's protocol ID
- K180603J
- Other IDs
- 2018-A01647-48
- Acronym
- RAPIDIRM
- Status last verified
- Oct 2021
- First submitted
- 24 May 2019
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Advanced MRI Acquisition Techniques for Perfusion and Diffusion to Detect Breast Cancer
- ClinicalTrials.gov ID
- NCT04020523
- Acronym / sponsor ID
- RAPIDIRM / K180603J
- Conditions
- Breast Cancer
- Keywords
- MRI, breast, cancer, screening, innovative sequences
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Delayed start due to technical problems as well as the covid pandemic. Decision of the investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Jul 2019 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective monocentric longitudinal study on a consecutive population of patients who require breast MRI as part of their course of care in the radiology department of the Tenon Hospital (3T MRI).
The standard protocol for breast MRI routinely performed in Tenon hospital consists of a set of MR acquisitions performed with contrast agent injection. The research consists of adding perfusion and diffusion sequences to the regular MR protocol. The addition of these sequences does not require a new injection of contrast medium.
Diagnosis of lesions after the breast MR exam will be performed using standard MR sequences as usual. According to the recommendations of SIFEM, the final diagnosis of the lesions will be made either by histological analysis of a biopsy performed as part of the patient's standard care pathway, or during patient's follow-up if a biopsy is not indicated (up to two years after breast MR exam).
The research will focus on evaluating the sensitivity and specificity of perfusion MRI sequence with or without diffusion MRI sequence compared to the sensitivity and specificity of the standard protocol.
For the perfusion sequence, the following data will be extracted: qualitative (shape of the contrast curve), semi-quantitative (elevation slope and asymptote of the curve) and quantitative by compartmental modeling (tissue perfusion, blood volume fraction, surface capillary permeability).
For the diffusion MRI, the extraction of quantitative data such as CDA, IVIM and Kurtosis will be performed and parametric maps, cellularity maps and an assessment of lesion heterogeneity will be calculated.
A correlation will be made with histological, immunohistochemical and molecular results of cancers following biopsy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with an injected breast MR exam | Experimental | Other: MRI sequence |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients under guardianship or curatorship
- Pregnant or breastfeeding patients
- Patients with contraindications to realization of an MR exam and an injected MR exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI sequenceThe MR sequences added to the protocol are dedicated sequences for perfusion and diffusion imaging of breast lesion. | Other | Patient with an injected breast MR exam |
Primary outcome
Mammary lesions Visualization on ultrafast injected dynamic MRI: Yes/No
Time frame: Day 1 at inclusion
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
Mammary lesions Visualization with a diffusion sequence
Time frame: Day 1 at inclusion
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
7 secondary outcomes
Quantitative perfusion parameters : Enhancement Integral (EI (%))
Time frame: Day 1 at inclusion
Quantitative perfusion parameters : Maximum Slope of Increase (MSI (%/sec))
Time frame: Day 1 at inclusion
Quantitative perfusion parameters : Maximum of enhancement (Rmax (%))
Time frame: Day 1 at inclusion
Quantitative perfusion parameters : Timing of Maximum of enhancement (RmaxTiming (sec))
Time frame: Day 1 at inclusion
Quantitative perfusion parameters : Wash-inrate (WIR (%/sec)
Time frame: Day 1 at inclusion
Correlate diffusion MRI parameters with immunochemical markers of tumor angiogenesis on anatomopathological specimen Quantitative diffusion parameter : Apparent Coefficient Diffusion
Time frame: Day 1 at inclusion
Evaluate the reduction in the time required to acquire and interpret the new breast MR protocol compared to the standard one
Time frame: Day 1 at inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle THOMASSIN-NAGGARA, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing MRI sequence in people with Breast Cancer, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammary lesions Visualization on ultrafast injected dynamic MRI: Yes/No (time frame: Day 1 at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.