Molecular Imaging Assessment of ACL Viability

NCT03491046 | Unknown FDA Device

• 1 other identifier: RP0649/2013H0009
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to answer the following questions:

1. 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. 2.What is the appearance of the native ACL on Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI)?

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (4)

• metabolic activity in the ACL graft

  We will assess the metabolic activity in the ACL graft by measuring the maximum standard uptake value of the PET signal within the graft, bone tunnels, and surrounding healthy tissue.

  through study completion, an average of 2-5 years

• feasibility of imaging

  We will determine the feasibility of imaging ACL grafts using FDG PET/CT by performing imaging in a variety of patients, with different surgical techniques and times since surgery. Whether a sufficiently measurable signal is achieved will be evaluated alongside the signal in the healthy, control knee of each patient.

  through study completion, an average of 2-5 years

• the ability of coregistration of PET and MR

  We will evaluate the ability to coregister separately acquired PET and MR images by creating a foam mold of the MRI knee coil to be used as a positioning device during the separate PET/CT imaging. We will assess the impact of motion artifacts on both image data sets as well.

  through study completion, an average of 2-5 years

• dynamic uptake rate of FDG in the ACL graft

  The PET images will be acquired in a dynamic mode, meaning they can be reconstructed into frames of different durations over the total 75 minute scan time. We will assess the uptake at the end of the 75 minute imaging period, as well as the dynamic uptake rate of FDG in the ACL graft, to learn whether the rate of uptake can provide additional insight into the healing process.

  through study completion, an average of 2-5 years

Study Arms (2)

Patient population with ACL injury or reconstruction

EXPERIMENTAL

Device: PET scan; Device: MRI scan

Patient population without ACL injury or reconstruction

EXPERIMENTAL

Device: PET scan; Device: MRI scan

Interventions

PET scan DEVICE

low dose fluorodeoxyglucose (FDG) PET research scan with CEST sequence

Patient population with ACL injury or reconstruction; Patient population without ACL injury or reconstruction

MRI scan DEVICE

standard of care MRI

Patient population with ACL injury or reconstruction; Patient population without ACL injury or reconstruction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients between 18 and 60 years of age.
• Patients scheduled for a standard of care MRI at OSU.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Positron-Emission Tomography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Michael V Knopp, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 9, 2018
• Study Start: October 9, 2013
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (1)