Malignant neoplasm of unknown primary site Trials in Disease

Study to Identify Unknown Primary Cancer Using [18F]-AlF-FAPI-74 PET-CT for Patients with Carcinoma of Unknown Primary

This clinical trial is designed for patients who have been diagnosed with cancer that has spread to other parts of the body, but where doctors have been unable to find where the cancer originally started. This condition is called Carcinoma of Unknown Primary, or CUP. The study will use a special imaging technique to try to locate the primary tumor.

Who can participate:

• Adults who are 18 years old or older
• Patients who have confirmed metastatic disease (cancer that has spread) without finding the original tumor after standard tests
• Patients who have already undergone standard testing, including a special scan called [18F]FDG PET-CT
• Both men and women can take part
• Patients who are not considered part of a vulnerable population requiring special protection

Who cannot participate:

• Patients who do not have a diagnosis of Carcinoma of Unknown Primary
• Patients who are not within the specified age range (younger than 18 years)
• Patients who belong to vulnerable populations that may need special protection or care

What the trial involves:

The main goal of this study is to determine how effective a new imaging technique called [18F]F-FAPI PET-CT is at identifying the primary tumor in patients with CUP. The trial uses a special imaging agent called [18F]-AlF-FAPI-74, which is designed to highlight cancer cells during the scanning process. This agent works by binding to a protein called fibroblast activation protein, which is often found in higher amounts in cancerous tissues.

Participants will receive an injection of the [18F]-AlF-FAPI-74 solution into a vein, followed by a PET-CT scan. This scan combines two imaging techniques to provide detailed pictures of the inside of the body. The doctors will then assess whether this method can accurately detect the primary tumor that other standard tests have not been able to find.

The investigational drug:

The study uses [18F]F-FAPI, a special imaging agent that helps doctors see where cancer cells might be located. It is administered through the PET-CT scan process and is classified as a diagnostic radiopharmaceutical. This means it is used for imaging purposes rather than as a treatment. The agent makes it easier for doctors to see potential cancer sites on the scan by highlighting areas where cancer cells may be present.

The study is expected to continue until 2026, with recruitment starting in 2024. This trial takes place in the Netherlands.