NCT03491046

Molecular Imaging Assessment of ACL Viability

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to answer the following questions: 1. Does the appearance of the reconstructed anterior cruciate ligament (ACL) vary in appearance on PET/MRI depending on graft type and time after surgery? 2. What is the appearance of the native ACL on Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI)?

Detailed description

This Phase I feasibility trial will evaluate knee injuries utilizing a standard of care non-contrast 3 Tesla (T) MRI. In addition, knee injuries will be assessed with a low dose (1/5 of the dose given for standard of care PET scans) fluorodeoxyglucose (FDG) PET research scan with CEST sequences. Patients enrolled in this study will include both those with and without a history of ACL repair; however, patients receiving the standard of care MRI will not be currently suspected of having an ACL injury based on physical examination and history. Patients with and without a history of ACL reconstruction will undergo a low dose FDG PET scan in the same setting as their MRI. The PET examination will be performed such that the early phase of imaging is performed prior to the MRI and the delayed phase is completed immediately following the MRI. This dual-phase scanning will allow for both assessment of the vascularity of the graft as well as its metabolic activity. Patients will be asked to provide study personnel with authorization to their medical records regarding the outcome of the knee graft. This authorization will be provided for 10 years from date of signed consent. Comparisons of the finding in normal and reconstructed ligaments as well as between graft types based on time from reconstruction will demonstrate the feasibility of this imaging technique and allow for generation of an imaging based hypothesis that will provide metabolic activity of the graft in a post-operative knee.

Conditions

• ACL Injury

Interventions

Type	Name	Description
DEVICE	PET scan	low dose fluorodeoxyglucose (FDG) PET research scan with CEST sequence
DEVICE	MRI scan	standard of care MRI

Timeline

• Start date: 2013-10-09
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-04-09
• Last updated: 2024-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study