Single-tracer Multiparametric PET Imaging

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called positron emission tomography (PET) that uses a single tracer, 18F-fluorodeoxyglucose (FDG), to look at both blood flow and how the body uses glucose. The researchers believe that this method can provide important information about heart health for both healthy individuals and those with cardiovascular diseases.

To participate, you need to be an adult aged 18 or older and willing to follow the study guidelines, which include fasting for at least 6 hours before the scan and lying still for up to 60 minutes. Healthy volunteers should not have a history of heart or metabolic diseases, while those with cardiovascular conditions are welcome to take part. Participants will undergo a PET scan, which is a special imaging test that helps doctors see how well the heart and other organs are functioning. It's important to note that the trial is currently recruiting participants, and all necessary precautions, including a pregnancy test for eligible women, will be taken to ensure safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Inclusion Criteria for all research participants:
• • Adults (age ≥ 18 years old)
• • Ability to understand and willingness to sign an informed consent form
• • Ability to adhere to the study visit schedule and other protocol requirements.
• • Willing and able to fast for at least 6 hours before and for the duration of the scan
• • No strenuous exercise for 24 hours prior to being scanned
• • Willing to lie on the scanner bed for up to 60 minutes
• • Free of active COVID-19 symptoms
• 2. Inclusion Criteria for healthy volunteers only:
• • • Free of history of cardiovascular, inflammatory, infections or metabolic diseases that would result in changes in normal tissue perfusion and/or metabolism.
• 3. Inclusion Criteria for patients with disease:
• • Patients with clinically acute or chronic conditions such as cardiovascular, cardiometabolic, or cardiopulmonary diseases, which may include but are not limited to ischemic heart disease, myocarditis, arrhythmias, heart failure, nonalcoholic fatty liver disease, COVID-related sequala, diabetes, hypertension, or renal disease that would result in changes in normal tissue perfusion and/or metabolism.
• Exclusion Criteria:
• Participants are not eligible if they meet ANY of the following criteria:
• • Self-reported history of dysphoria or anxiety in closed spaces
• • Body weight \>240 kg due to limitations of the scanner bed
• • Pregnant or breast-feeding (due to risks of ionizing radiation; urine pregnancy test will be administered prior to start of each PET/CT session for all participants between 18 to 60 years old who are able to get pregnant, unless documented hysterectomy or bilateral ovarian removal is available)
• • Blood glucose greater than 200 as assessed by fingerstick method before injection of 18F-FDG
• • Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.
• • Prisoners
• • Any condition that would prevent the understanding or rendering of informed consent.
• • Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives.