Prostate cancer, renal cancer, and urothelial carcinoma, including urothelial carcinoma of the bladder, renal pelvis, and ureter, across localized, locally advanced, and metastatic stages.
Conditions
Interventions
Gold Standard:Histopathological examination and immunohistochemical assessment of surgical or biopsy specimens matched to the lesions evaluated by PET/CT. The TROP2 immunohistochemistry H-score of the
Index test:68Ga-MY6349 TROP2-targeted nanobody PET/CT for participants in the TROP2 cohort and 68Ga-HP-ARK2 HER2-targeted nanobody PET/CT for participants in the HER2 cohort. The index test includes q
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The participant voluntarily agrees to participate in the study and provides written informed consent approved by the ethics committee; 2. The participant is 18 to 80 years of age at the time of signing the informed consent form, with no restriction on sex; 3. The participant has a clinical and/or pathological diagnosis of prostate cancer, renal cancer, or urothelial carcinoma, is scheduled to undergo surgical resection or biopsy, and can provide pathological tissue corresponding to the imaged lesion for immunohistochemical evaluation; 4. The participant is able to tolerate PET/CT examination and complete the study procedures in accordance with the protocol; 5. The participant has not received antitumor treatment that may substantially affect the assessment of target-antigen expression within 4 weeks before enrollment; 6. The participant has an estimated life expectancy of at least 12 weeks; 7. Female participants of childbearing potential must have a negative pregnancy test within 7 days before administration of the investigational radiotracer. Pregnant or breastfeeding women are not eligible; 8. The participant has generally adequate organ function, with no clinically significant severe abnormalities in hematology, liver function, renal function, coagulation function, or other examinations, as determined by the investigator, and is considered able to complete the study safely; 9. The participant is able to understand the study and its requirements, is considered by the investigator to have adequate compliance, and is able to complete the required visits, investigational radiotracer administration, PET/CT imaging, laboratory examinations, and other study-related procedures.
Exclusion criteria
Exclusion criteria: 1. Known severe hypersensitivity to the investigational radiotracer or any of its components; 2. Claustrophobia or any other condition that prevents the participant from tolerating PET/CT examination; 3. There are uncontrolled severe systemic diseases, such as active infections, severe liver and kidney dysfunction, unstable cardiovascular diseases, or conditions that the researchers consider to affect the safety of the study; 4. Active infection, including active hepatitis B, active hepatitis C, HIV infection, active tuberculosis, or another infection requiring systemic treatment, when the investigator considers the participant unsuitable for enrollment; 5. Pregnancy or breastfeeding; 6. Participation in another clinical study that may affect the results of this study within 30 days before enrollment; 7. A psychiatric or cognitive disorder that prevents the participant from providing informed consent or completing study follow-up; 8. Those who have had or are currently associated with other malignant tumors and whose researchers determine that it may affect the imaging evaluation, target antigen expression interpretation or subject safety of this study; However, low-risk malignant tumors that have received radical treatment and have no evidence of recurrence, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignant tumors that the researcher determines do not affect the evaluation of this study, may not be used as exclusion criteria; 9. Inability to obtain pathological tissue corresponding to the imaged lesion, or anticipated inability to complete immunohistochemical testing; 10. Inability to complete investigational radiotracer administration or image acquisition because of inadequate venous access, inability to maintain the required examination position, or other reasons; 11. Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation and agreement between investigational PET/CT quantitative parameters and target-antigen IHC H-score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-level and lesion-level detection rates of investigational PET/CT;Differences in the relationship between investigational PET/CT parameters and target-antigen H-score across clinicopathological subgroups;Diagnostic performance of investigational PET/CT for detecting TROP2 or HER2 expression;Incidence and characteristics of adverse events and serious adverse events during the study;Comparison of lesion detection and semiquantitative parameters between investigational PET/CT and 18F-FDG PET/CT; | — |
Countries
China
Contacts
Public ContactZhang Shudong
Peking University Third Hospital
Outcome results
None listed