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Corticosteroid
Triamcinolone Acetonide for Fibromatosis
Phase 1
Waitlist Available
Led By Benjamin K Wilke, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This study is evaluating whether triamcinolone injections are effective in treating desmoid tumors.
Eligible Conditions
- Fibromatosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate of desmoid tumors to serial triamcinolone injections based on RECIST.
Response rate of desmoid tumors to serial triamcinolone injections based on WHO criteria.
Response rate of desmoid tumors to serial triamcinolone injections based on change in T2 signaling hyperintensity.
+1 moreSecondary outcome measures
Number of patients experiencing a serious adverse event following triamcinolone injections.
Number patients experiencing a non-serious adverse event following triamcinolone injections.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Triamcinolone armExperimental Treatment1 Intervention
A concentration of 40 mg/ml of Triamcinolone Acetonide will be used for injections with a total dose of 120 mg of Triamcinolone given per injection. The injections will be performed under ultrasound guidance by a fellowship-trained musculoskeletal radiologist. The injection locations will be left to the discretion of the radiologist with the request to attempt to distribute the drug throughout the tumor. A total of three injections will be performed at six week intervals.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone Acetonide
2018
Completed Phase 4
~3730
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,767,001 Total Patients Enrolled
Benjamin K Wilke, MDPrincipal InvestigatorMayo Clinic
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