Study of Melanoma-Resistant PET Monitoring Based on Key Rate-limiting Enzymes for Fatty Acid Metabolism in Healthy Volunteers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXijing Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE PET/CT

    Diagnostic test

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Safety assessmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The maximum standardized uptake value (SUVmax)

The maximum standardized uptake value (SUVmax) of 68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE in the target population.

Time frame
One hour after injection of the tracer

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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