Clinical trial · Interventional
A Multicenter Study Evaluating the Diagnostic Value of 68Ga-MY6349 PET/CT for Prostate Cancer
- 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 main objective of this research is to develop and evaluate new PET imaging agents with high sensitivity and specificity for prostate cancer and other aggressive tumors. Specifically, the research focuses on improving upon existing prostate cancer imaging methods, such as PSA tests and PSMA PET/CT, which have limitations in sensitivity, specificity, and the ability to provide comprehensive tumor information，and aims to create a novel PET probe targeting Trop2, an antigen highly expressed in multiple cancer types, to enable in vivo, whole-tumor assessment. This would support early diagnosis, more precise staging, and effective monitoring of cancer therapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Positron-Emission Tomography(PET) | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Trophoblast Cell Surface Antigen 2 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standard-of-care imaging 68Ga-MY6349 and 68Ga-PSMA-11 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-MY6349
- description
- Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
- interventionNames
- Diagnostic Test: standard-of-care imaging 68Ga-MY6349 and 68Ga-PSMA-11
Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- 2 years
- description
- The sensitivity, specificity, and accuracy of 68Ga-MY6349 and 68Ga-PSMA-1PET/CT were calculated and compared to evaluate the diagnostic accuracy.
Secondary outcomes (2)
- measure
- Number of lesions
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with initial diagnosis of prostate cancer, or patients with biochemical recurrence after radical prostatectomy or radical radiotherapy. 2. Estimated survival time \>3 months, as determined by a physician. 3. Willing to sign the informed consent form voluntarily and able to comply with the study protocol. Exclusion Criteria: 1. Individuals unable to tolerate intravenous administration (e.g., history of needle or blood phobia). 2. Patients deemed unsuitable by researchers or unable to complete PET or other imaging examinations due to specific conditions, such as claustrophobia or radiophobia. 3. Individuals with occupational exposure to radiation. 4. Patients with severe diseases affecting the heart, kidneys, lungs, vascular, neurological, or mental systems, immune deficiency disorders, or hepatitis/cirrhosis. 5. Other conditions that researchers deem unsuitable for participation in the study.
References
Publications (0)
Data not yet available