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RecruitingNCT07327684

Photoacoustic/Ultrasound Imaging of Brown Adipose Tissue Activity

Research on the Morphology and Functional Assessment of Brown Adipose Tissue With Photoacoustic Imaging

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Peking Union Medical College Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

The goal of this study is to develop a novel, non-invasive, real-time photoacoustic imaging (PAI) technology for quantifying brown adipose tissue (BAT) and to investigate the differences in BAT morphology and metabolic function between healthy individuals and patients with metabolic syndrome. The main questions it aims to answer are: 1. Can PAI technology quantify BAT metabolic function and establish standardized PAI parameters for BAT assessment? 2. Can PAI parameters distinguish the BAT characteristics of healthy volunteers from patients with metabolic syndrome? Both healthy adults and patients diagnosed with metabolic syndrome will be recruited. Participants will undergo PAI scans of BAT region under normal conditions and after cold exposure to assess BAT activation. The ultimate goal is to validate this radiation-free PAI method as a convenient and effective tool for evaluating BAT metabolism, potentially aiding in early diagnosis and treatment monitoring of metabolic syndrome.

Detailed description

Brown adipose tissue (BAT) is a thermogenic organ that plays a beneficial role in whole-body metabolism by burning calories to generate heat. Its activity is inversely associated with obesity, insulin resistance, and metabolic syndrome. A key challenge in advancing BAT research and its clinical translation is the lack of a non-radiative, non-invasive imaging technique suitable for repeated use in both healthy and diseased populations. The current gold standard, \[¹⁸F\]FDG-PET/CT, involves ionizing radiation, limiting its application in longitudinal studies and healthy volunteer screening. Photoacoustic imaging (PAI) is an emerging hybrid modality that combines high optical contrast with deep ultrasound penetration. It can uniquely quantify tissue composition by detecting intrinsic contrasts like lipids and hemoglobin, making it ideally suited for assessing BAT's lipid content, blood perfusion and vascular oxygenation, which are key aspects of its metabolic function. The objectives of this study are: 1. To develop and technically optimize a non-invasive, real-time PAI protocol for quantitative characterization of human BAT morphology and metabolic function. 2. To establish a set of standardized, quantitative PAI parameters (e.g., related to blood perfusion, lipid composition, blood oxygen saturation) for BAT assessment. 3. To compare the baseline PAI parameters of BAT between healthy volunteers and patients with metabolic syndrome. Both healthy control group and the patient group will be recruited to undergo PAI scans targeting the supraclavicular BAT depots. All scans will be performed under normal conditions and a standardized cold exposure protocol to stimulate BAT activity. Quantitative PAI parameters (e.g., total hemoglobin, lipid concentration, oxygen saturation) will be extracted and compared between the Healthy Control group and the Patient group using appropriate statistical tests. This study will not only develop a novel PAI technology for BAT imaging but also utilize it to directly investigate a critical biological question: how BAT differs between health and disease. By establishing PAI-based biomarkers that can distinguish these states, this research aims to provide a powerful, radiation-free tool for the early detection of metabolic dysfunction, risk stratification, and objective monitoring of therapeutic efficacy for insulin resistance and related metabolic syndrome.

Conditions

Interventions

TypeNameDescription
DEVICEMulti-wavelength PA/US imaging scanning and cold exposureParticipants will undergo multi-wavelength PAI scans of BAT region under normal conditions and after 30-60 mins cold exposure to assess BAT activation.
DEVICEMulti-wavelength PA/US imaging scanning and cold exposureParticipants will undergo multi-wavelength PAI scans of BAT region under normal conditions and after 30-60 mins cold exposure to assess BAT activation.

Timeline

Start date
2025-05-22
Primary completion
2026-12-31
Completion
2027-12-31
First posted
2026-01-08
Last updated
2026-01-08

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07327684. Inclusion in this directory is not an endorsement.