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

A

Air Force Military Medical University of People's Liberation Army

Status

Not yet enrolling

Conditions

Health Volunteers
Melanoma (Skin Cancer)
PET / CT

Treatments

Diagnostic Test: 68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT07114172
KY20252266

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Safety assessment
Experimental group
Treatment:
Diagnostic Test: 68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE PET/CT

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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