ACL InjuryNCT03491046
Molecular Imaging Assessment of ACL Viability
A study testing PET scan and MRI scan in people with ACL Injury, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- PET scan and MRI scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2013to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients between 18 and 60 years of age.
- Patients scheduled for a standard of care MRI at OSU.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43221
About this study
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)?
Read the 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.
- Conditions
- ACL Injury
- Being tested
- PET scan, MRI scan
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scanDevice
low dose fluorodeoxyglucose (FDG) PET research scan with CEST sequence
MRI scanDevice
standard of care MRI
| Study group | Role | What they receive |
|---|---|---|
| Patient population with ACL injury or reconstruction | Experimental | Not described Receives: Device: PET scan; Device: MRI scan |
| Patient population without ACL injury or reconstruction | Experimental | Not described Receives: Device: PET scan; Device: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start9 Oct 2013
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael V Knopp MD PhD, University of Cincinnati
- Investigators
- Michael V Knopp, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491046
- Sponsor's protocol ID
- RP0649/2013H0009
- Status last verified
- Jan 2024
- First submitted
- 30 Mar 2018
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging Assessment of ACL Viability
- ClinicalTrials.gov ID
- NCT03491046
- Acronym / sponsor ID
- RP0649/2013H0009
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 9 Oct 2013 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female patients between 18 and 60 years of age.
- Patients scheduled for a standard of care MRI at OSU.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scanlow dose fluorodeoxyglucose (FDG) PET research scan with CEST sequence | Device | Patient population with ACL injury or reconstruction, Patient population without ACL injury or reconstruction |
| MRI scanstandard of care MRI | Device | Patient population with ACL injury or reconstruction, Patient population without ACL injury or reconstruction |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael V Knopp, MD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET scan and MRI scan in people with ACL Injury, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic activity in the ACL graft (time frame: through study completion, an average of 2-5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.