Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

Diabetes Mellitus Clinical Trial

Official title:

Radiotracer Imaging of Skeletal Muscle Perfusion in Patients With Peripheral Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03622359
• Other study ID #: IRB18-00442
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2017
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: Nationwide Children's Hospital
• Contact: Mitchel R Stacy, Ph.D.
• Phone: 614-355-5836
• Email: Mitchel.Stacy[@]nationwidechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

PAD patients (n=80) with peripheral artery disease (PAD) who are scheduled to undergo lower extremity revascularization procedures will be recruited. Patients will be screened using a standard medical history questionnaire and a physical activity questionnaire. Once their questionnaires are reviewed, individuals who meet inclusion criteria will proceed with standard PAD screening, which will include Ankle-Brachial Indices (ABIs) and Toe-Brachial Indices (TBIs) of both lower extremities. Patients will undergo SPECT/CT or PET/CT perfusion imaging prior to their revascularization procedure and 1-14 days following revascularization. Subjects will receive an intravenous injection of a standard clinical dose of radiotracer for both imaging sessions. A low-dose CT scan will be performed immediately after each SPECT and PET image acquisition for the purposes of attenuation correction and regional analysis of radiotracer uptake. Clinical outcomes will be evaluated for up to 12 months after the imaging study to assess the prognostic value of perfusion imaging for predicting subsequent outcomes. An additional subset of PAD patients (n=56) and healthy control subjects (n=56) will be enrolled to undergo the same imaging procedures to establish a healthy database for PET perfusion imaging measures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: December 31, 2028
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Patients with Peripheral Artery Disease:

1. At least 18 years of age

2. Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior ABI, TBI, CT angiography, ultrasound, or MR imaging.

Exclusion Criteria for Patients with Peripheral Artery Disease:

1. Unable to give informed consent or follow-up

2. Pregnant or nursing

3. Under the age of 18

4. No history of peripheral artery disease

Inclusion Criteria for Healthy Control Subjects:

1. At least 18 years of age

2. No evidence or prior diagnosis of peripheral artery disease based on chart review and standard vascular screening.

Exclusion Criteria for Healthy Control Subjects:

1. Unable to give informed consent of follow-up

2. Pregnant or nursing

3. Under the age of 18

4. History of peripheral artery disease

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Diabetes Mellitus
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Diagnostic Test:
• SPECT/CT perfusion imaging
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
• PET/CT perfusion imaging
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Nationwide Children's Hospital	Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Alvelo JL, Papademetris X, Mena-Hurtado C, Jeon S, Sumpio BE, Sinusas AJ, Stacy MR. Radiotracer Imaging Allows for Noninvasive Detection and Quantification of Abnormalities in Angiosome Foot Perfusion in Diabetic Patients With Critical Limb Ischemia and N — View Citation

Chou TH, Alvelo JL, Janse S, Papademetris X, Sumpio BE, Mena-Hurtado C, Sinusas AJ, Stacy MR. Prognostic Value of Radiotracer-Based Perfusion Imaging in Critical Limb Ischemia Patients Undergoing Lower Extremity Revascularization. JACC Cardiovasc Imaging. — View Citation

Chou TH, Atway SA, Bobbey AJ, Sarac TP, Go MR, Stacy MR. SPECT/CT Imaging: A Noninvasive Approach for Evaluating Serial Changes in Angiosome Foot Perfusion in Critical Limb Ischemia. Adv Wound Care (New Rochelle). 2020 Mar 1;9(3):103-110. doi: 10.1089/wou — View Citation

Chou TH, Nabavinia M, Tram NK, Rimmerman ET, Patel S, Musini KN, Eisert SN, Wolfe T, Wynveen MK, Matsuzaki Y, Kitsuka T, Iwaki R, Janse SA, Bobbey AJ, Breuer CK, Goodchild L, Malbrue R, Shinoka T, Atway SA, Go MR, Stacy MR. Quantification of Skeletal Musc — View Citation

Chou TH, Rimmerman ET, Patel S, Wynveen MK, Eisert SN, Musini KN, Janse SA, Bobbey AJ, Sarac TP, Atway SA, Go MR, Stacy MR. Vessel-by-vessel analysis of lower extremity 18F-NaF PET/CT imaging quantifies diabetes- and chronic kidney disease-induced active — View Citation

Chou TH, Stacy MR. Clinical Applications for Radiotracer Imaging of Lower Extremity Peripheral Arterial Disease and Critical Limb Ischemia. Mol Imaging Biol. 2020 Apr;22(2):245-255. doi: 10.1007/s11307-019-01425-3. — View Citation

Chou TH, Tram NK, Eisert SN, Bobbey AJ, Atway SA, Go MR, Stacy MR. Dual assessment of abnormal microvascular foot perfusion and lower extremity calcium burden in a patient with critical limb ischemia using hybrid SPECT/CT imaging. Vasc Med. 2021 Apr;26(2) — View Citation

Chou TH, Wynveen MK, Rimmerman ET, Patel S, Go MR, Stacy MR. Detection of multivessel calcific disease progression in a patient with chronic limb-threatening ischemia using fluorine-18 sodium fluoride positron emission tomography imaging. J Vasc Surg Case — View Citation

Rimmerman ET, Musini KN, Chou TH, Wynveen MK, Patel SA, Beall M, Bobbey AJ, Atway SA, Go MR, Stacy MR. Vessel-by-Vessel Computed Tomography Calcium Scoring of the Foot in Peripheral Artery Disease: Association with Patient-Level Factors. Adv Wound Care (N — View Citation

Stacy MR. Molecular Imaging of Lower Extremity Peripheral Arterial Disease: An Emerging Field in Nuclear Medicine. Front Med (Lausanne). 2022 Jan 12;8:793975. doi: 10.3389/fmed.2021.793975. eCollection 2021. — View Citation

Tram NK, Chou TH, Patel S, Ettefagh LN, Go MR, Atway SA, Stacy MR. Novel Application of 18F-NaF PET/CT Imaging for Evaluation of Active Bone Remodeling in Diabetic Patients With Charcot Neuropathy: A Proof-of-Concept Report. Front Med (Lausanne). 2022 Feb — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremity perfusion	The percent or absolute change in perfusion from baseline to post-revascularization will be evaluated.	1-2 weeks
Secondary	Wound healing	Rates of wound healing will be documented for 12 months following enrollment into the imaging study.	1 year
Secondary	Limb salvage	Amputation rates will be documented for the 12 months following enrollment into the imaging study.	1 year