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

NCT ID: NCT07114172

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2025-10-15

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.

Conditions

Melanoma (Skin Cancer); Health Volunteers; PET / CT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Safety assessment

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

68Ga-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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

KY20252266

Identifier Type: -

Identifier Source: org_study_id