Clinical trial · Interventional
Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
Open-label, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
NCT07615101CI-TRIAL-00122259recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.
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 |
|---|---|---|---|
| Prostate Cancer (Diagnosis) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68-Ga-NYM032 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68-Ga-NYM032
- interventionNames
- Drug: 68-Ga-NYM032
Primary outcomes (1)
- measure
- sensitivity and specificity
- timeFrame
- up to 30 days
- description
- Assessing the sensitivity and specificity of 68Ga-NYM032 Injection positron emission tomography (PET) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient is male and aged \>18 years old. 2. Biopsy proven prostate adenocarcinoma. 3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND). 4. ECOG performance status 0-2; expected survival ≥ 6 months. 6\. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: * 1\. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection. 2\. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection. 3\. Known hypersensitivity to the active ingredient or excipients of the study drug. 4\. Participants not capable of getting PET study , or inability to lay still for the duration of the exam. 5\. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.