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NOT YET RECRUITING
NCT07835906
PHASE1/PHASE2

68Ga-NYM215 in NENs

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Official title: Safety, Biodistribution, Dosimetry of 68Ga-NYM215 PET/CT and Head-to-head Comparison With 68Ga-DOTATATE PET/CT in Patients With Neuroendocrine Neoplasms: A Prospective Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-09-10

Completion Date

2027-10-20

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

68Ga-NYM215 PET/CT

40 patients will be enrolled in this arm. Each patients will be injected with approximately 3mCi 68Ga-NYM215. The first 8 participants will undergo serial 68Ga-NYM215 PET imaging at 5, 15, 30, 45, 60, and 120 minutes after 68Ga-NYM215 administration. Subsequent participants will undergo whole-body 68Ga-NYM215 PET/CT at 40 to 60 minutes after administration.

DIAGNOSTIC_TEST

68Ga-DOTATATE PET/CT

Each patients will be injected with approximately 3mCi 68Ga-DOTATATE. All participants will undergo whole-body 68Ga-DOTATATE PET/CT at 40 to 60 minutes after radiotracer administration. The two PET/CT examinations will be performed within 1 week, with an interval of at least 24 hours to minimize potential cross-interference.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China