Table of Contents
- Trial overview
- Who can participate
- What is being measured
- Trial phase and design
- Trial status and size
- Patient terms explained
Trial overview
The clinical trial identified as 2023-505453-40-00 is studying 99MTC-EUK-(SO3)CY5-MAS3 in people with prostate cancer.[1] The trial title is DUAL, and it is an interventional study, which means the research team gives the study intervention and then measures the results.[1]
The source data also lists the intervention as “hybrid PSMA (INTRAVENOUS ADMINISTRATION),” but it does not provide more detail beyond that name.[1]
Who can participate
The target population for this study is people with prostate cancer.[1] The source information does not give more detailed inclusion or exclusion rules, so the main known requirement is the disease being studied.[1]
What is being measured
The main outcome is the presence of lesion-specific uptake of 99mTc-hPSMA by prostate cancer.[1] In simple terms, the study is checking whether the test substance is seen in the cancer spots, which can help show if the target areas are detected clearly.[1]
The brief summary says the purpose is to confirm lesion-specific uptake of 99mTc-hPSMA by prostate cancer.[1] This makes the imaging result the central focus of the trial.[1]
Trial phase and design
This study is in Phase 1/2.[1] Phase 1/2 studies are early clinical studies that often combine first testing in people with an early look at whether the study approach gives useful results.[1]
The trial is listed as interventional, meaning the researchers actively apply the study intervention rather than only observing what happens naturally.[1]
Trial status and size
The trial status is Authorised.[1] This means the study has been approved to proceed according to the source record.[1]
The planned enrollment is 13 participants, so this is a small study.[1] Small early studies are often used to gather initial information before larger research is done.[1]
Patient terms explained
Uptake means how much of the study substance is taken into a body area or seen in a scan.[1] Lesion means an abnormal area, such as a tumor spot.[1]
Primary outcome is the main result the researchers want to measure.[1] In this trial, that main result is whether 99MTC-EUK-(SO3)CY5-MAS3 shows up in the prostate cancer lesions.[1]
Enrollment is the planned number of people who will join the study.[1] Here, the planned number is 13.[1]
