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MRI Coil
Advanced Fetal MRI for Pregnancy Imaging
N/A
Recruiting
Led By P. Ellen Grant, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gestational age between 18 and 40 weeks
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up july 2016-december 2019, up to 41 months
Awards & highlights
Study Summary
This trial is designed to improve fetal MRI imaging by creating MRI coils specifically for pregnant women and testing new MRI image acquisition techniques.
Who is the study for?
This trial is for pregnant women with either a healthy pregnancy or concerns for fetal abnormalities, between 18 and 40 weeks of gestation. They must be referred for an MRI by their obstetrician if there are concerns. Women can't join if they're claustrophobic, have metal implants, non-removable piercings, pacemakers, or are medically unstable.Check my eligibility
What is being tested?
The study tests a new MRI coil designed specifically for pregnant women alongside advanced image acquisition techniques to improve the quality of fetal MRI images compared to current methods.See study design
What are the potential side effects?
Since this trial involves standard MRI procedures with a specialized coil and no drugs or invasive treatments are used, significant side effects aren't expected. However, discomfort from lying still may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 weeks pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ july 2016-december 2019, up to 41 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~july 2016-december 2019, up to 41 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Research fetal MRI image quality compared to standard clinical fetal MRI image quality
Secondary outcome measures
Research MRI physiological data compared against standard obstetric physiological data obtained from ultrasound
Research fetal MRI image quality compared to standard obstetric ultrasound image quality
Side effects data
From 2021 Phase 2 trial • 7 Patients • NCT01585402100%
Diarrhea
71%
Myalgia
71%
Fatigue
71%
Nausea
71%
Arthralgia
57%
Hypernatremia
57%
Vomiting
43%
Headache
43%
Anemia
43%
Dizziness
43%
Dysgeusia
43%
Hypertriglyceridemia
43%
Palpitations
43%
Sinus bradycardia
43%
Back pain
43%
Flu like symptoms
29%
Bloating
29%
Constipation
29%
Dental caries
29%
Weight loss
29%
Abdominal pain
29%
Skin infection
29%
Gastroesophageal reflux disease
29%
Cholesterol high
29%
Anxiety
29%
Upper respiratory infection
29%
Paresthesia
29%
Anorexia
29%
Neck pain
29%
Dyspepsia
29%
Alanine aminotransferase increased
29%
Weight gain
29%
Bone pain
29%
Rash maculo-papular
29%
Hematuria
29%
Hypertension
14%
Fracture
14%
Urinary tract infection
14%
External iliac artery stenosis
14%
Jump graft on the bypass area declining function of previous graft
14%
Dry mouth
14%
Dysphagia
14%
Hyperkalemia
14%
Lymphocyte count decreased
14%
Osteoporosis
14%
Pain in extremity
14%
Gastritis
14%
Hypercalcemia
14%
Aspartate aminotransferase increased
14%
Esophagitis
14%
Left inguinal hernia surgery
14%
Stroke
14%
Lung infection
14%
Periodontal disease
14%
Toothache
14%
Depression
14%
Vivid dreams
14%
Sore throat
14%
Creatinine increased
14%
Calcaneus spur
14%
Joint inflammation/pain
14%
Pelvic pain
14%
Cold symptoms
14%
Strep agalactiae Urinary tract infection
14%
Malaise
14%
Memory impairment
14%
Syncope
14%
Elevated urine phosphorus
14%
Renal calculi
14%
Urinary frequency
14%
Arthralgia flare swelling of right hand
14%
Arthralgia flare swelling of right wrist
14%
Swelling of finger on fourth MCP of right hand
14%
Non-cardiac chest pain
14%
Pain
14%
Streptococcus pyogenes
14%
Premature atrial contractions
14%
Chest pain - cardiac
14%
Cough
14%
Dyspnea
14%
Postnasal drip
14%
White blood cell decreased
14%
Flank pain
14%
Ear pain
14%
Presyncope
14%
Somnolence
14%
Edema limbs
14%
Hemorrhoids
14%
Injection site reaction
14%
Lower gastrointestinal hemorrhage
14%
Hypocalcemia
14%
Hypercholesterolemia
14%
Hyperphosphatemia
14%
Left atrial enlargement; Incomplete right bundle branch block
14%
Sinus tachycardia
14%
Allergic reaction
14%
Pain of skin
14%
Blister on right 4th toe
14%
Dry eye
14%
Laryngitis
14%
Hemoglobinuria
14%
Skin ulceration
14%
Hyperparathyroidism
14%
Hypotension
14%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Etidronate Treatment for Arterial Calcifications Due to Deficiency in CD73 (ACDC)
Trial Design
2Treatment groups
Experimental Treatment
Group I: 60 minute research full MRI scanExperimental Treatment2 Interventions
Pregnant women who are able to have an MRI are eligible for the 60 minute research full MRI scan. Pregnant women may have a healthy pregnancy, a concern for fetal/placental abnormalities with a clinical fetal MRI ordered by their doctor, or a concern for fetal/placental abnormalities without a clinical fetal MRI ordered by their doctor.
The investigational MRI coil designed for pregnant women and research MRI sequences will be tested during the 60 minute research scan.
Group II: 15 minute research add-on MRI scanExperimental Treatment1 Intervention
Pregnant women with a concern for fetal/placental abnormalities with a clinical fetal MRI at Boston Children's Hospital are eligible for the 15 minute research add-on MRI scan.
The research MRI sequences will also be tested during the add-on research MRI scan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI Scan
2012
Completed Phase 2
~1420
Find a Location
Who is running the clinical trial?
Massachusetts Institute of TechnologyOTHER
97 Previous Clinical Trials
12,729,687 Total Patients Enrolled
Boston Children's HospitalLead Sponsor
766 Previous Clinical Trials
5,580,489 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,941 Previous Clinical Trials
13,200,369 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- should eat a healthy dietI am between 18 and 40 weeks pregnant.You are pregnant and have a fear of enclosed spaces.
Research Study Groups:
This trial has the following groups:- Group 1: 60 minute research full MRI scan
- Group 2: 15 minute research add-on MRI scan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals aged 55 and over being recruited for this research endeavor?
"The age range for this clinical trial is specified as being between 18 and 45 years old. Patients who are younger than 18 or older than 65 can join one of the 21 respective studies targeting their demographic."
Answered by AI
Are there any prerequisites for those interested in taking part of this experiment?
"To be eligible for this clinical trial, potential participants must demonstrate that they are pregnant and between the ages of 18-45. Approximately 300 individuals will ultimately take part in the study."
Answered by AI
How many volunteers are participating in this research effort?
"Affirmative. The clinicaltrials.gov registry shows that this experiment, which was initially announced on the 1st of July 2016, is currently recruiting individuals. 300 participants are needed from a single medical facility."
Answered by AI
Are there still enrollment opportunities available for this research endeavor?
"Affirmative. According to the clinicaltrials.gov, this trial is recruiting participants. The listing was first published on July 1st 2016 and has been revised most recently on August 10th 2022 as it looks for 300 people from one medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Boston Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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