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NCT07835906
68Ga-NYM215 in NENs
Conditions: Neuroendocrine Neoplasms
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 40
Sponsor: Peking Union Medical College Hospital
Location: Peking Union Medical College Hospital Beijing Beijing Municipality
Summary
This prospective study will evaluate the safety, biodistribution, dosimetry, and imaging performance of 68Ga-NYM215 PET/CT in patients with neuroendocrine neoplasms. An head-to-head comparison with 68Ga-DOTATATE PET/CT will assess the diagnostic performance of 68Ga-NYM215 PET/CT at both the patient and lesion levels.
Eligibility Criteria
Inclusion Criteria:
* Aged 18 to 80 years.
* Histopathologically confirmed neuroendocrine tumor.
* At least one suspected lesion based on other imaging findings or clinical assessment.
Exclusion Criteria:
* Combined with other types of tumors.
* Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR#30ml/min).
* Active infection.
* Pregnant or breastfeeding women.
* Inability to undergo PET/CT imaging.
Source: ClinicalTrials.gov (NCT07835906). StuddyBuddy aggregates publicly available trial information.