Health Volunteers, Melanoma (Skin Cancer), PET / CT
Conditions
Brief summary
This is a small-sample safety study involving 15 healthy volunteers who were divided into groups and underwent 68Ga-ACC-DE, 68Ga-FASN-DE, and 68Ga-ACLY-DE PET/CT imaging for safety, biodistribution, and radiation dosimetry assessments, laying the foundation for subsequent studies on the efficacy of resistance monitoring in melanoma targeted therapy.
Interventions
DIAGNOSTIC_TEST68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE PET/CT
Recruit 15 healthy adult volunteers, divided into three groups, to undergo dynamic PET/CT (1 hour) and static PET/CT (2 hours and 3 hours) imaging with 68Ga-ACC-DE, 68Ga-FASN-DE, or 68Ga-ACLY-DE, respectively, to assess safety, biodistribution, and radiation dosimetry, laying the foundation for subsequent studies.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18 to 65 years old (including the boundary values); Gender: Male or female; Weight: Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI = weight (kg) / height² (m²)) within the range of 18.0 to 28.0 kg/m² (including boundary values); Participants must fully understand and voluntarily participate in this experiment and sign an informed consent form.
Exclusion criteria
* Individuals who cannot tolerate intravenous administration (e.g., those with a history of fainting from needles or blood); Individuals with alcohol allergies; Pregnant or breastfeeding women; Individuals with severe diseases of the heart, kidneys, lungs, blood vessels, nervous system, or mental health, immune deficiency diseases, or hepatitis/cirrhosis; Individuals whom the investigator deems unsuitable for or unable to complete PET or other imaging examinations for special reasons; Other circumstances deemed by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum standardized uptake value (SUVmax) | One hour after injection of the tracer | The maximum standardized uptake value (SUVmax) of 68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE in the target population. |
Outcome results
None listed