Clinical trial · Interventional
ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors
ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors and Compared with 18F-FDG
NCT06188468CI-TRIAL-00083876completedN/AClinicalTrials.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 objective of the study is to construct a noninvasive approach 68Ga-MY6349 PET/CT to detect the Trop-2 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from Trop-2 targeting antibody-drug conjugate treatment.
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 | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT), 68Ga-MY6349 PET/CT | 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 (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT), 68Ga-MY6349 PET/CT
Primary outcomes (1)
- measure
- Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in various cancer types.
- timeFrame
- 1 week
- description
- Tumor Trop2 expression analysis in a fresh biopsy sample will be correlated to 68Ga-MY6349 tumor uptake, evaluated by measuring standardized uptake value (SUV) on the 68Ga-MY6349 PET/CT.
Secondary outcomes (2)
- measure
- To investigate the superiority of 68Ga-MY6349 PET/CT over 18F-FDG PET/CT in some tumors through comparative analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. adult patients (aged 18 years or older); 2. patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); 3. patients who had scheduled both standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT) and 68Ga-MY6349 PET/CT scans; 4. patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: 1. patients with pregnancy; 2. the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
References
Publications (1)
- DERIVEDChen H, Zhao L, Pang Y, Shi J, Gao H, Sun Y, Chen J, Fu H, Cai J, Yu L, Zeng R, Sun L, Wu H, Wang Z, Wang F. 68Ga-MY6349 PET/CT imaging to assess Trop2 expression in multiple types of cancer. J Clin Invest. 2024 Nov 7;135(1):e185408. doi: 10.1172/JCI185408. PMID 39509246