NCT07365397
Imaging Characteristics of Different ⁶⁸Ga-PSMA Probes in Prostate Cancer
Not Yet Recruiting · Not Applicable · Shanghai Zhongshan Hospital · registry updated 2026-01-26
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- The subject has fully understood the trial content, process, and potential risks, and has voluntarily signed the informed consent form;
- Male subjects aged ≥ 18 years;
- Clinically or radiologically assessed as metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC);
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Presence of positive lesions on ⁶⁸Ga-PSMA-11 PET/CT scan;
- Blood routine, renal function, and liver function tests meeting the following criteria:
Exclusion
- 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.