Clinical trial · Interventional
Trop2-targeted immunoPET Imaging of Solid Tumors
- 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 study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Nasopharyngeal Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]F-RESCA-RT4 | Drug | — | UNRESOLVED |
| [18F]F-RESCA-T4 | Drug | — | UNRESOLVED |
| [68Ga]Ga-NOTA-RT4 | Drug | — | UNRESOLVED |
| [68Ga]Ga-NOTA-T4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trop2-targeted immunoPET imaging
- description
- Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.
- interventionNames
- Drug: [68Ga]Ga-NOTA-T4
- Drug: [68Ga]Ga-NOTA-RT4
- Drug: [18F]F-RESCA-T4
- Drug: [18F]F-RESCA-RT4
Primary outcomes (10)
- measure
- Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.
- timeFrame
- 1 day from injection of the tracers
- description
- Measurement of the overall biodistribution of the above tracers in normal tissues and organs (bladder (after voiding), background (pelvic fat), blood, brain, salivary and lacrimal glands, lung, liver, spleen, pancreas, small intestine, and kidneys). To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18-75 year-old and of either sex * Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) by diagnostic imaging; * Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol. Exclusion Criteria: * Pregnancy； * Severe hepatic and renal insufficiency; * Allergic to single-domain antibody radiopharmaceuticals.
References
Publications (1)
- DERIVEDLong X, An S, Nian X, Xu D, Wei W, Lan X, Dong L, Jiang D. Trop2 immuno-PET/CT imaging of prostate cancer: a proof-of-concept translational study. BMC Med. 2025 Dec 31;24(1):66. doi: 10.1186/s12916-025-04589-8. PMID 41469668