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

Trial Summary

What is the purpose of this trial?

The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery disease (PAD) who are undergoing lower extremity revascularization procedures. We hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.

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 data supports the effectiveness of the treatment PET/CT perfusion imaging for Peripheral Arterial Disease?

Research shows that PET myocardial perfusion imaging (MPI) is more accurate and uses lower radiation doses compared to SPECT MPI for detecting coronary artery disease, which suggests it could be effective for other conditions like Peripheral Arterial Disease. Additionally, combining PET with CT can improve diagnostic accuracy by assessing both anatomy and blood flow. ^{1 2 3 4 5}

Is perfusion imaging safe for humans?

Perfusion imaging, including methods like SPECT and CT, is generally considered safe for humans, with mild and rare adverse events reported in studies. However, there can be serious complications under certain conditions, and the safety may vary depending on the patient's risk factors and the specific imaging method used. ^{6 7 8 9 10}

How does perfusion imaging differ from other treatments for peripheral arterial disease?

Perfusion imaging for peripheral arterial disease is unique because it provides detailed information about blood flow and the physiological impact of arterial blockages, which helps in treatment planning. Unlike traditional methods, it offers a non-invasive way to assess how well blood is reaching different parts of the leg, complementing other diagnostic tools like arteriography. ^{11 12 13 14 15}

Research Team

Mitchel R Stacy, Ph.D.

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

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.

I am 18 years old or older.

Exclusion Criteria

I am under 18 years old.

Pregnant or nursing

I have never had peripheral arterial disease.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Potential of F-18 Flurpiridaz PET/CT Myocardial Perfusion Imaging for Precision Imaging. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Cardiac image fusion from stand-alone SPECT and CT: clinical experience. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Myocardial perfusion imaging with PET. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Improved Performance of PET Myocardial Perfusion Imaging Compared to SPECT in the Evaluation of Suspected CAD. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

CT imaging of myocardial perfusion: possibilities and perspectives. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A case report: adenosine triggered myocardial infarction during myocardial perfusion stress test imaging in a diabetic patient. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Ambulatory cardiac single-photon emission computed tomography at the primary care physician's office: a descriptive study. [2010]

8. Turkey pubmed.ncbi.nlm.nih.gov

Predictors and Diagnostic Significance of the Adenosine Related Side Effects on Myocardial Perfusion SPECT/CT Imaging. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Diagnostic safety of a machine learning-based automatic patient selection algorithm for stress-only myocardial perfusion SPECT. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Current status of cardiac CT for the detection of myocardial ischemia. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Unenhanced Velocity-Selective MR Angiography (VS-MRA): Initial Clinical Evaluation in Patients With Peripheral Artery Disease. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Peripheral MR angiography. [2009]

13. United States 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. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Peripheral vascular perfusion scanning. Correlation with the arteriogram and clinical assessment in the patient with peripheral vascular disease. [2019]

15. England pubmed.ncbi.nlm.nih.gov

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