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Molecular Imaging Assessment of ACL Viability

Primary Purpose

ACL Injury

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET scan
MRI scan
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient population with ACL injury or reconstruction

Patient population without ACL injury or reconstruction

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2018
Last Updated
June 28, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT03491046
Brief Title
Molecular Imaging Assessment of ACL Viability
Official Title
Molecular Imaging Assessment of ACL Viability
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 9, 2013 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to answer the following questions: Does the appearance of the reconstructed anterior cruciate ligament (ACL) vary in appearance on PET/MRI depending on graft type and time after surgery? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient population with ACL injury or reconstruction
Arm Type
Experimental
Arm Title
Patient population without ACL injury or reconstruction
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PET scan
Intervention Description
low dose fluorodeoxyglucose (FDG) PET research scan with CEST sequence
Intervention Type
Device
Intervention Name(s)
MRI scan
Intervention Description
standard of care MRI
Primary Outcome Measure Information:
Title
metabolic activity in the ACL graft
Description
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.
Time Frame
through study completion, an average of 2-5 years
Title
feasibility of imaging
Description
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.
Time Frame
through study completion, an average of 2-5 years
Title
the ability of coregistration of PET and MR
Description
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.
Time Frame
through study completion, an average of 2-5 years
Title
dynamic uptake rate of FDG in the ACL graft
Description
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.
Time Frame
through study completion, an average of 2-5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael V Knopp, MD, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States

12. IPD Sharing Statement

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Molecular Imaging Assessment of ACL Viability

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