Molecular Imaging of Lower Extremity Peripheral Arterial Disease: An Emerging Field in Nuclear Medicine.
Mitchel R Stacy
https://pubmed.ncbi.nlm.nih.gov/35096884/Actively Recruiting
Led by Nationwide Children's Hospital · Updated on 2025-04-01
192
Participants Needed
1
Research Sites
17 weeks
Total Duration
This research aims to create a healthy database for nuclear perfusion imaging of the lower legs and to evaluate how well radiotracer-based imaging predicts clinical outcomes in patients with peripheral artery disease PAD undergoing lower leg revascularization. The study tests whether this imaging method can sensitively detect regional blood flow problems in leg muscles and monitor responses to treatment. Patients with PAD scheduled for revascularization will receive two types of imaging SPECTCT or PETCT perfusion scans. Each patient will get an intravenous injection of a radiotracer before and 1 to 14 days after their procedure. A low-dose CT scan will follow each imaging session for better image analysis. Additionally, a group of PAD patients and healthy volunteers will undergo the same imaging to help build a healthy reference database. Participants will complete medical and physical activity questionnaires, standard PAD screenings including Ankle-Brachial and Toe-Brachial Indices, and imaging sessions before and shortly after their revascularization. Researchers will monitor clinical outcomes such as wound healing and limb salvage for up to 12 months. The main measure is blood flow in the lower legs within 1 to 2 weeks after treatment, with ongoing safety and outcome tracking throughout the study period.
CONDITIONS
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
M
Mitchel R Stacy, Ph.D.
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Nationwide Children's Hospital
Lead Sponsor
Ohio State University
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | SPECT/CT Perfusion Imaging | PET/CT Perfusion Imaging | Doppler Ultrasound (Current Standard Practice) |
|---|---|---|---|
| What it is | A nuclear medicine imaging method that combines single photon emission computed tomography (SPECT) with CT to visualize and quantify blood flow in the lower extremities using a radiotracer. | A nuclear imaging technique that combines positron emission tomography (PET) with CT to assess and quantify lower limb blood flow using injected radiotracer agents. | An established non-invasive imaging procedure that uses Doppler ultrasound to assess blood flow and identify reduced perfusion or blockages in leg arteries. |
| Role in the trial | Assigned as an experimental imaging arm to evaluate lower extremity perfusion before and after revascularization. | Assigned as an experimental imaging arm for perfusion assessment before and after lower limb interventions. | Not included as a randomized trial arm but serves as the current standard diagnostic method for routine PAD evaluation. |
| Primary use | Non-invasively quantifying regional blood flow to the lower limbs in patients with PAD to assess perfusion changes due to vascular disease and following revascularization. | Measuring absolute and relative blood flow in the lower limbs among PAD patients before and after revascularization. | Routine screening and assessment of arterial blood flow, blockages, and perfusion deficits in the lower extremities in patients suspected of having PAD. |
| How it is performed | A small amount of radiotracer is injected, and SPECT scans are obtained to generate cross-sectional perfusion images, usually before and after a vascular procedure. | Radiotracer is administered intravenously, and whole-leg PET/CT imaging is performed to create quantitative perfusion maps. | A technician applies a handheld ultrasound device to the skin, using sound waves to measure real-time blood flow in arteries without radiation or contrast injection. |
| Evidence status | Early clinical studies show SPECT/CT can detect and quantify abnormal limb perfusion in critical limb ischemia and monitor changes after interventions, but larger studies are ongoing. | Initial research indicates PET/CT enables sensitive quantification of blood flow in PAD, but clinical utility for guiding treatment or predicting outcomes remains to be validated by prospective trials. | Supported by extensive real-world experience and guideline endorsement, Doppler ultrasound is validated for diagnosis, location, and monitoring of PAD and remains the most practical first-line tool. |
| Important limitations | Limited availability, radiation exposure, and cost, as well as the need for radiotracers and specialized imaging equipment, restrict general use. Lacks guideline support for PAD assessment at this time. | Requires specialized tracers, higher costs, limited clinical access, radiation exposure, and currently no guideline endorsement for PAD. Further clinical research and standardization are needed. | Operator skill affects accuracy, deeper or calcified vessels may be challenging to evaluate, and provides limited comprehensive evaluation of tissue perfusion compared to advanced nuclear imaging. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for medical history and physical activity questionnaires and standard PAD screening including Ankle-Brachial and Toe-Brachial Indices
Duration - 1 to 2 weeks
Participants undergo SPECT/CT or PET/CT perfusion imaging before and after their scheduled lower extremity revascularization procedure.
2 imaging visits (in-person): one prior to revascularization and one 1 to 14 days post-procedure
Duration - Up to 12 months
Participants are followed for clinical outcomes including wound healing and limb salvage for up to 12 months after imaging.
Follow-up assessments occur periodically over 12 months to evaluate clinical outcomes
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/38353265/Nationwide Children's Hospital
Lead Sponsor
Ohio State University
Collaborating Sponsor