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Molecular Imaging Assessment of ACL Viability

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ClinicalTrials.gov Identifier: NCT03491046
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Michael V. Knopp MD, PhD, Ohio State University

Brief 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)?

Condition or disease Intervention/treatment Phase
ACL Injury Device: PET scan Device: MRI scan Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Molecular Imaging Assessment of ACL Viability
Actual Study Start Date : October 9, 2013
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient population with ACL injury or reconstruction Device: PET scan
low dose fluorodeoxyglucose (FDG) PET research scan with CEST sequence

Device: MRI scan
standard of care MRI

Experimental: Patient population without ACL injury or reconstruction Device: PET scan
low dose fluorodeoxyglucose (FDG) PET research scan with CEST sequence

Device: MRI scan
standard of care MRI




Primary Outcome Measures :
  1. metabolic activity in the ACL graft [ Time Frame: through study completion, an average of 2-5 years ]
    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.

  2. feasibility of imaging [ Time Frame: through study completion, an average of 2-5 years ]
    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.

  3. the ability of coregistration of PET and MR [ Time Frame: through study completion, an average of 2-5 years ]
    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.

  4. dynamic uptake rate of FDG in the ACL graft [ Time Frame: through study completion, an average of 2-5 years ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491046


Contacts
Contact: Melanie Hughes 614-293-9998 office@wcibmi.org
Contact: Michael V Knopp, MD, PhD 614-293-9998 knopp.16@osu.edu

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Michael V Knopp    614-293-9998    knopp.16@osu.edu   
Sub-Investigator: David C Flanigan, MD         
Sub-Investigator: Timiothy Hewett, PhD         
Sub-Investigator: Christopher C Kaeding, MD         
Sub-Investigator: Robert A Magnussen, MD         
Sub-Investigator: Xiangyu Yang, PhD         
Sub-Investigator: Jun Zhang, PhD         
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Michael V Knopp, MD, PhD Ohio State University
  Study Documents (Full-Text)

Documents provided by Michael V. Knopp MD, PhD, Ohio State University:
Study Protocol  [PDF] March 13, 2013


Responsible Party: Michael V. Knopp MD, PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03491046     History of Changes
Other Study ID Numbers: RP0649/2013H0009
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries