Clinical trial · Interventional
Study of Melanoma-Resistant PET Monitoring Based on Key Rate-limiting Enzymes for Fatty Acid Metabolism in Healthy Volunteers
NCT07114172CI-TRIAL-00093426not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Health Volunteers | — | UNRESOLVED | — |
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| PET / CT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Safety assessment
- interventionNames
- Diagnostic Test: 68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE PET/CT
Primary outcomes (1)
- measure
- The maximum standardized uptake value (SUVmax)
- timeFrame
- One hour after injection of the tracer
- description
- The maximum standardized uptake value (SUVmax) of 68Ga-ACC-DE/68Ga-FASN-DE/68Ga-ACLY-DE in the target population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.