Clinical trial · Interventional
68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma
Study on the Clinical Application of GPC3-targeting 68Ga-NYM207 PET/CT in Hepatocellular Carcinoma
- 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 prospective, single-center, single-arm, phase I/II study designed to evaluate (1) the safety, tolerability, and imaging characteristics of 68Ga-NYM207 (Phase A), and (2) the diagnostic performance of 68Ga-NYM207 in detecting hepatocellular carcinoma (HCC) (Phase B). This study will provide critical insights into the performance of 68Ga-NYM207 PET/CT as a non-invasive imaging tool for the detection of HCC.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NYM207 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NYM207 PET/CT
- description
- 68Ga-NYM207 PET/CT Each patient will receive one dose of 68Ga-NYM207 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
- interventionNames
- Diagnostic Test: 68Ga-NYM207 PET/CT
Primary outcomes (2)
- measure
- Safety and tolerability after ⁶⁸Ga-NYM207 administration (Phase A)
- timeFrame
- From study completion to 1 month after completion
- description
- Number of adverse events associated with administration of ⁶⁸Ga-NYM207 will be recorded.
- measure
- Binary reading of focal lesions identified on 68Ga-NYM207 PET/CT (Phase B)
- timeFrame
- From study completion to 1 month after completion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥18 years of age and of either gender; 2. Written informed consent provided for participation in the trial; 3. At least one of the following indications should be applied: 1. scheduled for surgical resection or biopsy of the liver mass within one month; 2. with a history of HCC, recurrence or metastasis during follow-up (based on histopathologic examination or typical appearance of imaging data including conventional imaging or 18F-FDG PET/CT scan); 4. Willing and able to follow schedule visits, treatment plans and laboratory tests. Exclusion Criteria: 1. Pregnancy or lactation; 2. Severe claustrophobia; 3. On treatment with anti-tumor drugs targeting GPC3; 4. Any condition deemed by the investigator to interfere with study results or increase participant risk.
References
Publications (0)
Data not yet available