The feasibility of 18F-Fluoromisonidazole (18F-FMISO) imaging for atherosclerotic and non-atherosclerotic intra-arterial hypoxia.

Not Applicable

Recruiting

• Conditions: Cardiovascular Disease; Peripheral artery disease; Cardiovascular - Other cardiovascular diseases; Arterial calcification; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12622000442707
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-21
• Last Update Posted: 12 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Male or post-menopausal female (defined as the absence of menses of >12 months in the absence of pathology) above the age 40 who have undergone a clinical decision to proceed to below knee or above knee amputation
-A lower limb computed-tomography angiography performed in the last 18 months and performed exclusively for clinical purposes
-Have some evidence of arterial disease on lower limb computed-tomography angiography

Exclusion Criteria

-Inability to provide informed consent
-A diagnosis of chronic obstructive pulmonary disease or other respiratory disease that currently requires home oxygen therapy
-A resting oxygen saturation (measured at time of screening and in the absence of oxygen therapy) below 92%
-eGFR less than or equal to 30 at time of screening
-Symptomatic heart failure impairing an ability to lie flat on for imaging purposes or requiring supplemental oxygen therapy
-A prior below knee, above knee or higher, lower limb amputation of the other limb
-Acute lower limb ischemia requiring urgent revascularisation or emergent amputation
-Prior orthopaedic surgery of the lower limb with foreign material remaining in-situ
-In-patients requiring nurse escort for inter-hospital transport
-Recent or current lung cancer or cancer of the lower limb (excluding Non-melanoma skin cancer)
-Known cardiac arrhythmia that precludes ECG gating

Study & Design

• Study Type: Observational
• Study Design: Not specified