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Isovue for Pediatric Thyroid Function
Phase 4
Waitlist Available
Research Sponsored by Bracco Diagnostics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female from 0 to 3 years of age
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 12 months
Awards & highlights
Study Summary
This trial looks at the effects of a medical contrast agent on young children's thyroid function.
Who is the study for?
This trial is for children aged 0 to 3 who need a radiologic exam with Isovue as part of their usual care and have normal thyroid function tests. They can't join if they're allergic to Isovue, have congenital hypothyroidism, had head/neck radiation, are on thyroid drugs or treatments affecting the thyroid, used iodinated products recently, or had contrast agents within a year.Check my eligibility
What is being tested?
The study observes young patients after using Isovue in imaging procedures to see how often it causes abnormal thyroid function. It's an observational study where kids receive standard care and researchers track changes in their thyroid levels afterwards.See study design
What are the potential side effects?
Since this is an observational study focusing on the effects of Isovue on the thyroid, specific side effects aren't listed. However, general risks may include allergic reactions or other impacts related to contrast agent use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 3 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abnormal thyroid function
Secondary outcome measures
Hypothyroidism
Thyroid hormone replacement therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: ISOVUEExperimental Treatment1 Intervention
Isovue will be given to all subjects per the standard of clinical care.The specific iodine concentration and volume of ISOVUE used during the radiologic procedure will depend on the type of procedure and the standards in place at the site where the procedure is performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isovue
2014
Completed Phase 4
~150
Find a Location
Who is running the clinical trial?
Bracco Diagnostics, IncLead Sponsor
60 Previous Clinical Trials
9,803 Total Patients Enrolled
Mary Luigia Storto, MDStudy DirectorBracco Corporate
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on medication that could affect thyroid tests.My thyroid function tests are normal.I am 3 years old or younger.I have had radiation therapy on my head or neck.I am currently taking medication for my thyroid.I am scheduled for a scan that requires a special dye injection.I have been exposed to an iodine-based dye for scans or procedures within the last year.You are allergic to any of the ingredients in ISOVUE.I was born with an underactive thyroid.
Research Study Groups:
This trial has the following groups:- Group 1: ISOVUE
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 there opportunities to enroll in this experiment right now?
"Affirmative. According to the clinicaltrials.gov database, enrollment is still open for this trial which was posted on March 26th 2019 and last revised on February 28th 2022."
Answered by AI
Has Isovue been sanctioned by the U.S. Food and Drug Administration?
"The safety of Isovue is given a rating of 3, since the drug has been approved by the relevant medical authorities and is currently in Phase 4 clinical trials."
Answered by AI
How many participants are engaging in this research project?
"Indeed, the information on clinicaltrials.gov confirms that this medical trial is actively enrolling participants. The protocol was initially published on March 26th 2019 and updated most recently in late February 2022. This study requires around 1560 people to be recruited from one particular site."
Answered by AI
Could you elaborate on the other investigations conducted regarding Isovue?
"Presently, 4 clinical trials of Isovue are in progress with 0 Phase 3 studies. While the majority of these research projects take place in Omaha Nebraska, there is a total of 8 sites carrying out this investigation."
Answered by AI
Under what circumstances is Isovue typically utilized?
"Isovue is an efficient tool for urography, computerized tomography, and myelography."
Answered by AI
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