Breast Cancer, Prostate Cancer
Conditions
Interventions
Experimental group:All participants received 68Ga-ZS2004, 3–7 mCi per dose, administered intravenously as a single injection, PET/CT scans were performed at 60 and 90 minutes post-administration. As a
Sponsors
Chinese People's Liberation Army (PLA) General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Before participating in the study, a signed informed consent form must be obtained; 2. Age should be between 18 and 80 years old; 3. Patients diagnosed with breast cancer or prostate cancer through histological or cytological examination; or other patients whose condition is suspected by imaging and who plan to undergo surgery or biopsy at this hospital; 4. Breast cancer participants: priority will be given to those with newly diagnosed or recurrent metastatic estrogen receptor (ER) positive (>10%) and human epidermal growth factor receptor-2 (HER2) negative breast cancer; 5. Prostate cancer participants: can be included in those with newly diagnosed or recurrent metastatic prostate cancer; 6. Within 28 days before administration, there should be at least one assessable lesion identified by imaging or clinical judgment; 7. ECOG score should be 0-2; 8. Organ function should meet the following requirements: bone marrow reserve: neutrophil count (ANC) >=1.5×10^9/L, platelet count >= 90×10^9/L, hemoglobin >= 90 g/L; liver: total bilirubin (TBIL) = 50.
Exclusion criteria
Exclusion criteria: 1. Patients or researchers who are unable to undergo PET examination due to reasons such as weight, claustrophobia, radiation phobia, inability to remain still for a long time during the examination, etc., or who judge that the patient has any situation that cannot cooperate with imaging examination and operation; 2. Those with a history of other malignant tumors (except for patients who have undergone radical treatment, whose treatment before enrollment has been completed for more than 3 years and there is no evidence of recurrence or metastasis); 3. Those with severe or poorly controlled medical diseases, including but not limited to uncontrollable infections, severe cardiovascular diseases, acute coronary syndrome, severe liver and kidney failure, or other diseases that the researcher considers may affect the study; 4. Patients with central nervous system (CNS) metastases who have symptoms and require systemic hormone therapy; 5. Those who are expected not to complete two imaging examinations as per the protocol; 6. Pregnant or lactating women, and women of childbearing age whose pregnancy test is positive within 7 days before the administration of the study drug; 7. Patients who do not agree to take effective contraceptive measures during the study period and 4 weeks after drug administration; 8. Other situations that the researcher considers may significantly affect image interpretation or safety, or other conditions that make them unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, serious adverse events, laboratory tests, electrocardiograms, physical examinations and vital signs, etc.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biological distribution of normal organs and uptake of tumor lesions: SUVmax, SUVmean, TBR (with the preset background being liver/blood pool/muscle, respectively calculating T/L, T/B, T/M).; | — |
Countries
China
Contacts
Public ContactJinming.Zhang
Chinese People's Liberation Army (PLA) General Hospital
Outcome results
None listed