LUMIERE on the PLACENTA : A Study on the Added Value of MRI
LUMIERE on the PLACENTA
Sponsors
Source
Assistance Publique - Hôpitaux de Paris
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
The frequency of IUGR is between 3 and 10% of births. The etiologies and mechanisms of IUGR
are multiple. The placental insufficiency, that is the defect of perfusion, is, however, the
principal mechanism, far in front of other maternal or fetal causes. This placental
insufficiency is also now recognized as an essential risk factor for cardiovascular and
metabolic diseases, such as diabetes, in adulthood. The interest in understanding in utero
development is thus further increased by the short-, medium- and long-term consequences of
placental dysfunction. However, there are few ways to evaluate uteroplacental vascularization
in vivo. MRI is an imaging technique used routinely in the exploration of the fetus in
addition to ultrasound. Its safety on the fetus and the mother is largely demonstrated at
1.5T. There are also MRI sequences used daily in the clinic to evaluate perfusion and organ
structure in children and adults (brain, kidney, heart, etc.). Their application for
evaluation of perfusion and placental structure, although still confined to research, is very
promising. The investigator's team has extensive experience, in animals or in children, in
the use of these sequences that could be used to evaluate placental function in vivo. The ASL
(Arterial Spin Labeling) in particular is the most encouraging functional imaging technique
because it allows today to measure an organ blood flow quantitatively and without injection
of contrast medium.
Detailed Description
The inclusion will take place at the earliest at 20 weeks after the completion of the
standard morphological ultrasound of the 2nd trimester (carried out at 20-24SA) and at the
latest at 35 SA, within the framework of one of the 2 clinical subgroups of patients
considered (high risk and low risk).
The objectives of this study will be achieved by the prospective setting up of a LUMIERE
cohort on PLACENTA.
Overall Status
Not yet recruiting
Start Date
2019-12-01
Completion Date
2023-11-01
Primary Completion Date
2023-06-01
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Changes in placental blood flow as seen in vascular IUGR |
From inclusion to end of neonatal period (max 25 weeks) |
Secondary Outcome
Measure |
Time Frame |
|
Placental response to maternal oxygenation (BOLD) |
From inclusion to end of neonatal period (max 25 weeks) |
|
structural changes of the placenta |
From inclusion to end of neonatal period (max 25 weeks) |
|
structural changes of the placenta |
From inclusion to end of neonatal period (max 25 weeks) |
|
Measurement of placental volume |
From inclusion to end of neonatal period (max 25 weeks) |
|
Measurement of IUGR by fetal segmentation (MRI), |
From inclusion to end of neonatal period (max 25 weeks) |
|
evaluation of brain resonance |
From inclusion to end of neonatal period (max 25 weeks) |
|
evaluation of kidney resonance |
From inclusion to end of neonatal period (max 25 weeks) |
|
evaluation of liver resonance |
From inclusion to end of neonatal period (max 25 weeks) |
|
Reproducibility of the examination analysis |
After study completion, an average of one year |
|
Uterine arteries |
From inclusion to end of neonatal period (max 25 weeks) |
|
Acceptability of the examination for the patient: questionnaire |
at IRM examination |
|
Acceptability of the examination for the patient: Likert scale |
at IRM examination |
|
Specific Absorption Rate for each type of sequence |
From inclusion to end of neonatal period (max 25 weeks) |
Number Of Groups
2
Enrollment
250
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus(es)
Arm Group Label
Group 1: High risk IUGR patients
Group 2: Low risk IUGR patients
Eligibility
Study Pop
Pregnant patients with low and high risk of placental IUGR followed in the Fetal Medicine
Department of the Necker-Enfants Malades hospital.
Sampling Method
Non-Probability Sample
Criteria
Inclusion Criteria:
- Singleton pregnancy without fetal malformation seen on ultrasound. Group 1: High risk
IUGR patients
- EPF<10th perc or PA<10th perc and Doppler ombilical IP> 95th percentile,
- EPF or PA<3th perc reference curves from Collège Français d'Echographie Fœtale,
between 20 et 34 GW,
Group 2: Low risk IUGR patients
• EPF et PA>20th perc reference curves from Collège Français d'Echographie Fœtale, between
20 et 34 GW
Exclusion Criteria:
- - Contraindication to MRI
- Impossible subsequent follow up
- Maternal status contraindicates continuation of pregnancy
- Participation in another search
- "Protected" patient
Gender
Female
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Laurent Salomon, MD, PhD |
Principal Investigator |
Principal Investigator |
Overall Contact
Location
Facility |
Status |
Contact |
|
Necker - Enfants Malades Hospital Paris 75015 France |
Not yet recruiting |
Location Countries
Country
France
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Arm Group
Arm Group Label
Group 1: High risk IUGR patients
Description
EPF<10th perc or PA<10th perc and Doppler ombilical IP> 95th percentile, EPF or PA<3th perc (reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW),
Arm Group Label
Group 2: Low risk IUGR patients
Description
EPF et PA>20th perc (reference curves from Collège Français d'Echographie Fœtale, between 20 et 34 GW)
Firstreceived Results Date
N/A
Overall Contact Backup
Acronym
FETUS
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
September 17, 2019
Study First Submitted Qc
November 15, 2019
Study First Posted
November 18, 2019
Last Update Submitted
November 15, 2019
Last Update Submitted Qc
November 15, 2019
Last Update Posted
November 18, 2019
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.