Molecular Imaging Assessment of ACL Viability



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 60
Updated:6/23/2018
Start Date:October 9, 2013
End Date:December 31, 2020
Contact:Melanie Hughes
Email:office@wcibmi.org
Phone:614-293-9998

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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)?

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.

Inclusion Criteria:

- Male and female patients between 18 and 60 years of age.

- Patients scheduled for a standard of care MRI at OSU.

Exclusion Criteria:

- Patients with a suspected ACL injury.

- Patients who are pregnant or lactating.

- Patients who are prisoners.

- Patients who are unable to provide consent.

- Patient with significant renal insufficiency, i.e. an estimated glomerular filtration
rate (eGFR) less than 30 mL/min/1.73m2.

- Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit sever
vertigo when they are moved into the MR.

- Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic
means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators,
electronic infusion pumps, etc.).

- Subjects with any type of ferromagnetic bioimplant that could potentially be displaced
or damaged.

- Subjects that have vascular or aneurysm clips, or metallic staples from a surgical
procedure.

- Subjects with permanent tattoo eye liner (may contain metallic coloring).

- Subjects that may have shrapnel imbedded in their bodies, such as from war wounds,
metal workers and machinists (metallic fragments in or near eyes), severe auto
accident victims.
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-293-9998
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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mi
from
Columbus, OH
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