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PET/MRI Imaging for ACL Injury

N/A
Waitlist Available
Led By Michael V Knopp, MD, PhD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female patients between 18 and 60 years of age
Be between 18 and 65 years old
Must not have
Subjects with vascular or aneurysm clips, or metallic staples from a surgical procedure
Patients with a suspected ACL injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2-5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at the different ways to reconstruct the ACL, and how well they look on PET/MRI, over time.

Who is the study for?
This trial is for men and women aged 18-60 who are scheduled for a standard MRI at OSU. It's not suitable for those with certain bioimplants, metal in their body, pregnant or lactating individuals, prisoners, people unable to consent, those with severe kidney issues or metallic tattoos, and anyone anxious about MRIs.
What is being tested?
The study aims to understand how the reconstructed ACL looks on PET/MRI scans depending on graft type and time post-surgery. It also examines the appearance of native ACLs using these imaging techniques.
What are the potential side effects?
PET and MRI scans are generally safe but may cause discomfort due to lying still for long periods. There's a small risk of allergic reaction to contrast materials used in some cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have metal clips or staples from past surgery.
Select...
I might have an ACL injury.
Select...
My kidney function is significantly reduced.
Select...
I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2-5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
dynamic uptake rate of FDG in the ACL graft
feasibility of imaging
metabolic activity in the ACL graft
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patient population without ACL injury or reconstructionExperimental Treatment2 Interventions
Group II: Patient population with ACL injury or reconstructionExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET scan
2016
Completed Phase 2
~650
MRI scan
2022
Completed Phase 4
~2710

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
436 Previous Clinical Trials
635,296 Total Patients Enrolled
Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,095 Total Patients Enrolled
Michael V Knopp, MD, PhDPrincipal InvestigatorOhio State University
8 Previous Clinical Trials
438 Total Patients Enrolled

Media Library

PET scan Clinical Trial Eligibility Overview. Trial Name: NCT03491046 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: Patient population with ACL injury or reconstruction, Patient population without ACL injury or reconstruction
Anterior Cruciate Ligament Injury Clinical Trial 2023: PET scan Highlights & Side Effects. Trial Name: NCT03491046 — N/A
PET scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT03491046 — N/A
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