Perfusion Imaging for Peripheral Arterial Disease

Overseen By Ting-Heng Chou, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nationwide Children's Hospital

Disqualifiers: Pregnant, Nursing, Under 18, others

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

Compensation: Varies

Number of Visits: 3

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well new imaging techniques can predict outcomes for people with peripheral artery disease (PAD), a condition where narrowed leg arteries restrict blood flow. Researchers use two types of imaging—PET/CT perfusion imaging (Positron Emission Tomography/Computed Tomography) and SPECT/CT perfusion imaging (Single Photon Emission Computed Tomography/Computed Tomography)—to identify blood flow problems and guide treatment. It suits those scheduled for leg artery procedures due to blockages, as well as healthy individuals without PAD. As an unphased trial, this study allows participants to contribute to pioneering research that could enhance future PAD treatments.

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 these imaging techniques are safe for patients with peripheral artery disease?

Research has shown that PET/CT and SPECT/CT imaging are generally safe and easy for people to handle. These methods effectively show how blood moves through muscles. They are non-invasive, meaning they don't involve surgery or cutting into the body.

PET/CT and SPECT/CT are already used to check heart blood flow, which indicates their safety. However, some people might feel a bit warm or slightly uncomfortable during the scan.

The treatment in this study is at a stage where safety is a primary focus. Researchers closely monitor participants' reactions to these imaging tests. Any issues that arise will be quickly addressed. Overall, evidence supports the safety of these imaging tests for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PET/CT and SPECT/CT perfusion imaging for peripheral arterial disease because these imaging techniques offer a more detailed look at blood flow in the legs compared to traditional methods like ultrasound or MRI. Unlike standard imaging, PET/CT and SPECT/CT can provide precise maps of how well blood is reaching affected areas, which is crucial for planning effective revascularization procedures. This detailed information could lead to more personalized treatment plans and potentially better outcomes for patients with peripheral arterial disease.

What evidence suggests that PET/CT and SPECT/CT perfusion imaging could be effective for peripheral artery disease?

This trial will compare PET/CT perfusion imaging with SPECT/CT perfusion imaging for patients with peripheral artery disease (PAD). Studies have shown that PET/CT perfusion imaging holds promise for detecting and managing PAD by identifying blood flow problems in the legs, aiding in early diagnosis and treatment monitoring. Research also indicates that SPECT/CT imaging effectively evaluates blood flow and predicts outcomes for PAD patients, revealing how well blood reaches the muscles and how patients respond to treatments. Both imaging techniques offer valuable insights into managing PAD by accurately assessing blood flow. ^{1 4 6 7 8}

Who Is on the Research Team?

Mitchel R Stacy, Ph.D.

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with peripheral arterial disease (PAD), specifically diabetic patients needing lower extremity revascularization. They must have evidence of significant artery blockage in the legs, confirmed by previous medical imaging tests.

Inclusion Criteria

I have been diagnosed with blocked arteries in my legs.

Exclusion Criteria

I am under 18 years old.

Pregnant or nursing

I have never had peripheral arterial disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Imaging

Participants undergo SPECT/CT or PET/CT perfusion imaging before and 1-14 days after revascularization

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for clinical outcomes such as wound healing and limb salvage

12 months

Periodic follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• PET/CT perfusion imaging
• SPECT/CT perfusion imaging

Trial Overview

The study is testing two types of perfusion imaging: SPECT/CT and PET/CT to see how well they predict outcomes after leg blood flow restoration procedures in PAD patients. It aims to evaluate if these scans can effectively assess muscle blood supply issues and monitor treatment success.

How Is the Trial Designed?

Group I: SPECT/CT perfusion imaging Experimental Treatment 2 Interventions

Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo SPECT/CT imaging as part of the research protocol.

Group II: PET/CT perfusion imaging Experimental Treatment 2 Interventions

Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo PET/CT imaging as part of the research protocol.

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials

354

Recruited

5,228,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

The peripheral vascular perfusion scan provides unique insights into how arterial disease affects blood flow in the extremities, which can help surgeons determine the best treatment approach.

This scan complements traditional methods like arteriograms and clinical assessments rather than replacing them, offering additional information about the physiological significance of arterial lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral vascular perfusion scanning. Correlation with the arteriogram and clinical assessment in the patient with peripheral vascular disease. Siegel, ME., Giargiana, FA., White, RI., et al.[2019]

CT myocardial perfusion imaging is a safe and accurate method for assessing heart conditions, providing detailed anatomical visualization of coronary lesions and improving diagnostic accuracy for ischemic lesions.

Despite its benefits, the use of CT perfusion imaging is limited by concerns over radiation exposure and contrast load, and a standardized acquisition protocol is still needed, making it not yet a routine clinical practice compared to other imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of cardiac CT for the detection of myocardial ischemia. Schuhbäck, A., Marwan, M., Cury, RC., et al.[2021]

F-18 flurpiridaz is a promising new PET myocardial perfusion imaging agent that is close to regulatory approval and may significantly enhance the assessment of coronary artery disease due to its unique capabilities.

This agent offers excellent image quality and accurate blood flow quantification, making it potentially the best option for non-invasive evaluation of myocardial blood flow across diverse patient populations, regardless of size, gender, or exercise ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of F-18 Flurpiridaz PET/CT Myocardial Perfusion Imaging for Precision Imaging. Patel, KK., Singh, A., Bateman, TM.[2022]

Positron emission tomography (PET) myocardial perfusion imaging (MPI) offers significant advantages over single photon emission computed tomography (SPECT) MPI, including better image quality, higher diagnostic accuracy, shorter protocols, and lower radiation exposure for patients.

PET MPI can quantify absolute myocardial blood flow and assess conditions like diffuse atherosclerosis and microvascular dysfunction, which helps in identifying patients at higher risk for cardiac events and optimizing treatment strategies for coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Performance of PET Myocardial Perfusion Imaging Compared to SPECT in the Evaluation of Suspected CAD. Alam, L., Omar, AMS., Patel, KK.[2023]

Myocardial perfusion imaging (MPI) using SPECT is generally safe, but in this case, a 68-year-old female patient experienced an acute myocardial infarction during the procedure, highlighting potential risks associated with pharmacologic stress testing.

The incident suggests that reduced perfusion pressure and exhausted coronary autoregulation can lead to serious complications like thrombus formation during MPI-SPECT, emphasizing the importance of continuous monitoring during such tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case report: adenosine triggered myocardial infarction during myocardial perfusion stress test imaging in a diabetic patient. de Mulder, M., van Gameren, M., van Asperen, EA., et al.[2022]

Recent advancements in imaging techniques, particularly in MR angiography, have significantly improved the diagnosis of peripheral artery occlusive disease by enhancing spatial resolution and image quality.

New image reconstruction algorithms and dedicated contrast agents allow for time-resolved imaging, providing more detailed insights into the arterial conditions of the lower extremities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral MR angiography. Kramer, H., Nikolaou, K., Sommer, W., et al.[2009]

In a study of 281 patients undergoing adenosine stress myocardial perfusion imaging (MPI), 61.6% experienced side effects like flushing, dyspnea, and chest pain, with age ≤45 years and BMI ≥30 kg/m2 identified as independent predictors of these side effects.

Despite the occurrence of side effects, the diagnostic value of adenosine MPI using an integrated SPECT/CT system remained high, with a sensitivity of 86%, specificity of 94%, and overall diagnostic accuracy of 92% for detecting coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and Diagnostic Significance of the Adenosine Related Side Effects on Myocardial Perfusion SPECT/CT Imaging. Yıldırım Poyraz, N., Özdemir, E., Poyraz, BM., et al.[2023]

In a study of 38 patients with coronary artery disease, the use of 3D fused SPECT/CT images provided additional diagnostic information about the severity of coronary lesions in 22% of cases, significantly enhancing the evaluation of heart conditions.

The fused imaging technique was particularly beneficial for assessing small vessel stenoses and diagonal branches, confirming the importance of integrating different imaging modalities for better diagnosis and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac image fusion from stand-alone SPECT and CT: clinical experience. Gaemperli, O., Schepis, T., Valenta, I., et al.[2022]

PET-myocardial perfusion imaging (MPI) offers a highly accurate method for assessing heart blood flow and function in just 30 minutes, using tracers like rubidium-82 or nitrogen-13-ammonia, and is currently being enhanced with a new fluorine-18-based tracer.

Compared to traditional SPECT-MPI, PET-MPI not only provides higher diagnostic accuracy for detecting coronary artery disease but also does so with lower radiation exposure and shorter exam times, making it a safer and more efficient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myocardial perfusion imaging with PET. Nakazato, R., Berman, DS., Alexanderson, E., et al.[2021]

Unenhanced velocity-selective magnetic resonance angiography (VS-MRA) provides high-quality images of peripheral arteries, achieving an average image quality score of 2.7 to 2.8 out of 3, indicating good diagnostic potential for patients with peripheral artery disease (PAD).

The diagnostic performance of VS-MRA shows high sensitivity (up to 85.3%) and specificity (up to 96.8%) for detecting significant arterial stenosis when compared to digital subtraction angiography (DSA), demonstrating its effectiveness as a non-invasive imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unenhanced Velocity-Selective MR Angiography (VS-MRA): Initial Clinical Evaluation in Patients With Peripheral Artery Disease. Shin, T., Menon, RG., Thomas, RB., et al.[2023]

The study utilized 201Tl SPECT/CT imaging in a porcine model (n=8) to successfully monitor changes in lower extremity arteriogenesis and muscle perfusion after femoral artery occlusion, demonstrating its potential for evaluating peripheral arterial disease.

Four weeks post-occlusion, the imaging revealed significant increases in capillary density in ischemic muscles and correlated well with tissue activity measurements, indicating that this imaging technique could be effective for detecting disease progression and monitoring treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodality imaging approach for serial assessment of regional changes in lower extremity arteriogenesis and tissue perfusion in a porcine model of peripheral arterial disease. Stacy, MR., Yu, DY., Maxfield, MW., et al.[2021]

In a study of 249 patients with peripheral arterial occlusive disease (PAOD), fluorescein perfusography effectively visualized skin perfusion, revealing significant delays in fluorescein influx in patients with critical ischemia compared to those with less severe conditions.

The technique demonstrated a high accuracy of 93% in identifying critical limb ischemia, outperforming traditional ankle systolic arterial pressure measurements, which had an accuracy of 80%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topographical evaluation of skin perfusion patterns in peripheral arterial occlusive disease by means of computer-assisted fluorescein perfusography. Scheffler, A., Rieger, H.[2019]

In a 2-year study involving 1266 patients, ambulatory cardiac stress testing in primary care settings was found to be safe, with no serious adverse events like heart attacks or hospitalizations reported.

The study suggests that while this testing is safe for the general population, further research is needed to assess its appropriateness for higher-risk patients and its long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory cardiac single-photon emission computed tomography at the primary care physician's office: a descriptive study. Chaptini, N., Dontaraju, VS., Concepcion, F., et al.[2010]

A machine learning score (MLS) developed from stress-only myocardial perfusion imaging (MPI) demonstrated high sensitivity (95%) for predicting obstructive coronary artery disease (CAD) in a study of 2079 patients, allowing for the safe cancellation of unnecessary rest imaging.

The MLS outperformed traditional reader diagnoses and other methods in predicting CAD, achieving an area under the curve (AUC) of 0.84, which indicates its effectiveness in identifying both obstructive and high-risk CAD cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic safety of a machine learning-based automatic patient selection algorithm for stress-only myocardial perfusion SPECT. Eisenberg, E., Miller, RJH., Hu, LH., et al.[2023]

Functional imaging techniques, including Single-photon-emission computed tomography (SPECT) and stress perfusion magnetic resonance imaging, are highly accurate for detecting significant coronary artery disease (CAD) and identifying patients who may benefit from coronary revascularization.

Recent advancements in cardiac computed tomography (CT) allow for myocardial perfusion assessment (CT-MPI), showing promising diagnostic accuracy similar to traditional methods, but further studies are needed to evaluate its prognostic value and address concerns about radiation exposure and contrast agent use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT imaging of myocardial perfusion: possibilities and perspectives. Becker, A., Becker, C.[2021]

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