PET/MRI Imaging for ACL Injury

Overseen By Michael V Knopp, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Pregnancy, Renal insufficiency, Bioimplants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the appearance of the ACL (a key knee ligament) changes on PET/MRI scans based on different graft types and the time since surgery. It will also examine the appearance of a healthy ACL on these scans. The trial includes individuals with ACL injuries or reconstructions and those without. It suits individuals who need a standard MRI at OSU and have not had an ACL injury.

As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future ACL treatments and imaging techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that PET/MRI imaging is safe for ACL injury assessment?

Research has shown that PET/MRI scans are safe for studying ACL (anterior cruciate ligament) injuries. MRI often identifies and monitors ACL injuries without surgery. Studies confirm MRI's accuracy and importance in diagnosing ACL issues. PET scans, which reveal tissue activity, can detect changes after ACL surgery.

These imaging methods are generally easy for patients to handle and have not been linked to major side effects. Prospective participants in studies using these scans can feel confident in their widespread use and safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using PET/MRI imaging for ACL injuries because it combines the detailed anatomical view of MRI scans with the metabolic insights of PET scans. This dual approach offers a more comprehensive understanding of both the structure and function of the knee, potentially leading to more personalized treatment plans. Unlike traditional methods that might only use one type of imaging, this combination can help identify subtle changes in tissue that could impact recovery or treatment decisions.

What evidence suggests that PET/MRI imaging is effective for assessing ACL injuries?

Research shows that PET/MRI imaging is useful for studying ACL injuries. In this trial, participants will undergo PET/MRI imaging to assess its effectiveness. Studies have found that PET scans reveal increased activity in the whole knee after ACL surgery, which decreases over time, suggesting that PET can track the healing process. MRI accurately diagnoses ACL injuries, correctly identifying them 95.45% of the time and correctly ruling them out 91.67% of the time. This indicates that MRI is highly effective at spotting ACL injuries. PET/MRI combines these strengths, offering a detailed view of the knee's activity and structure. This imaging technique helps doctors better understand how the ACL and surrounding tissues change after surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Michael V Knopp, MD, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-60 who are scheduled for a standard MRI at OSU. It's not suitable for those with certain bioimplants, metal in their body, pregnant or lactating individuals, prisoners, people unable to consent, those with severe kidney issues or metallic tattoos, and anyone anxious about MRIs.

Inclusion Criteria

Patients scheduled for a standard of care MRI at OSU

Exclusion Criteria

I have metal clips or staples from past surgery.

I might have an ACL injury.

Subjects that may have shrapnel embedded in their bodies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo a low dose FDG PET scan and a standard of care MRI to assess the vascularity and metabolic activity of the ACL graft.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging assessment.

2-5 years

What Are the Treatments Tested in This Trial?

Interventions

• MRI scan
• PET scan

Trial Overview The study aims to understand how the reconstructed ACL looks on PET/MRI scans depending on graft type and time post-surgery. It also examines the appearance of native ACLs using these imaging techniques.

How Is the Trial Designed?

Group I: Patient population without ACL injury or reconstruction Experimental Treatment 2 Interventions

Group II: Patient population with ACL injury or reconstruction Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7264087/

PET/MRI reveals ongoing metabolic activity in ACL grafts one ... PET whole-knee activity was increased at all time-points post-operatively compared to the control, non-operative knee. Activity decreased over ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7812197/

The accuracy of MRI in the diagnosis of anterior cruciate ... The sensitivity, specificity, and accuracy of MRI in the diagnosis of ACL injury were 95.45% (63/66), 91.67%, and 94.87%, respectively. The ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S096801601730090X

ACL graft metabolic activity assessed by 18 FDG PET–MRI The PET/MRI data were collected at multiple time points after ACL reconstruction, revealing a significant decrease in metabolic activity of grafts that had been ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1063458418311427

Quantitative imaging of bone–cartilage interactions in ACL ... Magnetic resonance imaging (MRI) is used widely for the detection and monitoring of ACL injuries as well as to non-invasively study the complex disease ...

5. mdpi.com mdpi.com/2379-139X/10/8/94

Deep Learning-Assisted Automatic Diagnosis of Anterior ... This study aimed to develop a deep learning model for detecting ACL tears in knee magnetic resonance Imaging (MRI) to enhance diagnostic accuracy and ...

6. jscimedcentral.com jscimedcentral.com/jounal-article-info/Annals-of-Sports-Medicine-and-Research/Anterior-Cruciate-Ligament--Injuries%3A-MR-Imaging-Diagnosis--with-Surgical-Implications-11263

Anterior Cruciate Ligament Injuries: MR Imaging Diagnosis ... MR imaging is an accurate and important tool in diagnosing ACL injuries, and various primary and secondary signs of ACL injury have been reported.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11463185/

Magnetic Resonance Imaging of Anterior Cruciate Ligament ... This article outlines an effective MRI imaging technique that improves the diagnostic accuracy of ACL injuries of the knee, covering the appropriate pulse ...