Clinical trial · Interventional
68Ga-NYM215 in NENs
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
NCT07835906CI-TRIAL-00126543not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Neoplasms | Neuroendocrine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTATATE PET/CT | Diagnostic Test | — | UNRESOLVED |
| 68Ga-NYM215 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NYM215 and Comparator 68Ga-DOTATATE PET/CT
- description
- Patients will perform a 68Ga-NYM215 PET/CT as well as a 68Ga-DOTATATE PET/CT.
- interventionNames
- Diagnostic Test: 68Ga-NYM215 PET/CT
- Diagnostic Test: 68Ga-DOTATATE PET/CT
Primary outcomes (2)
- measure
- Diagnostic efficacy
- timeFrame
- At the time of paired PET/CT imaging, within 1 week.
- description
- 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).
- measure
- Safety
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.