68Ga-NYM215 in NENs

NCT07835906 | Not Yet Recruiting Phase 1

• 1 other identifier: PUMCH-NYNEN
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine Neoplasms

Outcome Measures

Primary Outcomes (2)

• Diagnostic efficacy

  Diagnostic efficacy of 68Ga-NYM215 PET/CT compared with 68Ga-DOTATATE PET/CT in the same participant, assessed on both a per-patient and per-lesion basis. Per-patient analysis will compare lesion detection rate. Per-lesion analysis will compare lesion detection rate, lesion number, size, SUVmax, and tumor-to-background ratio (TBR).

  At the time of paired PET/CT imaging, within 1 week.

• Safety

  Adverse effects after radiotracer injection.

  From radiotracer injection to 24 hours post-injection.

Secondary Outcomes (2)

• Biodistribution

  Through study completion, within 1 week.

• Dosimetry

  Through study completion, an average of 6 months.

Study Arms (1)

68Ga-NYM215 and Comparator 68Ga-DOTATATE PET/CT

EXPERIMENTAL

Patients will perform a 68Ga-NYM215 PET/CT as well as a 68Ga-DOTATATE PET/CT.

Diagnostic Test: 68Ga-NYM215 PET/CT; Diagnostic Test: 68Ga-DOTATATE PET/CT

Interventions

68Ga-NYM215 PET/CT DIAGNOSTIC_TEST

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.

68Ga-NYM215 and Comparator 68Ga-DOTATATE PET/CT

68Ga-DOTATATE PET/CT DIAGNOSTIC_TEST

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.

68Ga-NYM215 and Comparator 68Ga-DOTATATE PET/CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years.
• Histopathologically confirmed neuroendocrine tumor.
• At least one suspected lesion based on other imaging findings or clinical assessment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Central Study Contacts

Meixi Liu, MD

CONTACT

+86-15010405355; meixiliu_pumc@126.com

Huo Li, MD

CONTACT

+86-13910801986; huoli@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): September 10, 2027
• Study Completion (Estimated): October 20, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

CN (1)