Imaging Characteristics of Different ⁶⁸Ga-PSMA Probes in Prostate Cancer
Status
Conditions
Treatments
Details and patient eligibility
About
This study aims to evaluate the imaging characteristics of [⁶⁸Ga]Ga-GS24-B2-250-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-250-T), [⁶⁸Ga]Ga-GS24-B2-268-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-268-T), [⁶⁸Ga]Ga-GS24-B2-237-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-237-T), and [⁶⁸Ga]Ga-PSMA-11 Injection (abbreviated as ⁶⁸Ga-PSMA-11) as PET/CT imaging agents in patients with prostate cancer.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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The subject has fully understood the trial content, process, and potential risks, and has voluntarily signed the informed consent form;
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Male subjects aged ≥ 18 years;
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Clinically or radiologically assessed as metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC);
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
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Presence of positive lesions on ⁶⁸Ga-PSMA-11 PET/CT scan;
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Blood routine, renal function, and liver function tests meeting the following criteria:
- Platelet count > 90 × 10⁹/L;
- Urea/urea nitrogen and serum creatinine < 1.5 × upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN;
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Expected survival time ≥ 6 months;
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From the date of signing the informed consent form until 3 months after administration, the subject and his partner must use effective contraceptive measures, and the subject must avoid sperm donation.
Exclusion criteria
- Having participated in another interventional clinical trial prior to signing the informed consent form and being within 5 half-lives of the investigational product of that trial; or currently participating in another interventional clinical trial; or having participated in a clinical trial involving radiopharmaceuticals prior to signing the informed consent form with an interval of less than 3 months between the last dose and the informed consent signing date.
- Having received any intravenous iodine-containing contrast agent within 24 hours prior to administration, or any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to administration. Oral water-soluble contrast agents (e.g., compound meglumine diatrizoate oral solution) are acceptable.
- Having received high-energy γ-ray-emitting agents (>300 KeV, e.g., radiopharmaceuticals labeled with radionuclides such as [¹³¹I]I, [¹⁸F]F, [⁶⁸Ga]Ga, [⁶⁴Cu]Cu, etc.) within a period equivalent to either 5 half-lives of the agent or 2 days, whichever is longer, prior to administration.
- Planning to adjust anti-tumor medication during the study period.
- Being unable to complete the required PET/CT imaging procedures.
- Having any medical condition or other circumstances that, in the investigator's judgment, may affect the safety or compliance of the subject.
Trial design
Primary purpose
Allocation
Interventional model
Masking
9 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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