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

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What is this study about?

This clinical trial is focused on a condition known as Carcinoma of Unknown Primary (CUP). This is a type of cancer where the primary origin of the tumor is not identified despite thorough testing. The study will use a special imaging technique called [18F]F-FAPI PET-CT to help locate the primary tumor in patients diagnosed with CUP. The treatment involves an injection of a solution called [18F]-AlF-FAPI-74, which is a chemical substance designed to help highlight cancer cells during the imaging process.

The purpose of the study is to determine how effective the [18F]F-FAPI PET-CT scan is in identifying the primary tumor in patients with CUP. Participants will receive an injection of the [18F]-AlF-FAPI-74 solution, followed by a PET-CT scan. This scan combines two imaging techniques, PET (Positron Emission Tomography) and CT (Computed Tomography), to provide detailed pictures of the inside of the body. The study aims to see if this method can accurately detect the primary tumor that other standard tests have not been able to find.

Throughout the study, some participants may receive a placebo instead of the active solution to compare the results. The trial will assess the ability of the [18F]F-FAPI PET-CT to correctly identify the primary tumor and evaluate its sensitivity and specificity, which are measures of how well the test can detect the disease and distinguish it from other conditions. The study is expected to continue until 2026, with recruitment starting in 2024.

1 joining the study

Participation begins after meeting the eligibility criteria, which include being 18 years or older and having a confirmed metastatic disease without a known primary tumor, despite standard diagnostic procedures.

2 initial assessment

An initial assessment is conducted to confirm eligibility and gather baseline health information. This may involve reviewing medical history and previous diagnostic results.

3 administration of the solution

The medication used in this study is called [18F]-AlF-FAPI-74. It is a solution for injection administered intravenously. The exact dosage and frequency are determined by the study protocol and medical team.

4 PET-CT scan

After the injection, a PET-CT scan is performed. This imaging test helps to identify the primary tumor in patients with carcinoma of unknown primary origin. The scan uses the injected solution to highlight areas of interest.

5 follow-up and monitoring

Following the scan, there may be additional follow-up appointments to monitor health and assess the outcomes of the scan. The frequency and duration of these follow-ups depend on individual health needs and study requirements.

6 completion of participation

Participation in the study concludes after the final follow-up. The study is estimated to end by August 31, 2026, but individual participation may vary based on when one joins the study.

Who Can Join the Study?

Must be 18 years old or older.
Must have a confirmed spread of cancer to other parts of the body, known as metastatic disease, without finding the original tumor after standard tests.
The standard tests must include a special type of scan called [18F]FDG PET-CT.
Both men and women can participate.
Participants should not be from a vulnerable population, meaning they should not be in a group that needs special protection or care.

Who Cannot Join the Study?

Patients who are not diagnosed with Carcinoma of Unknown Primary cannot participate. This is a type of cancer where the original location of the cancer is not known.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Snagcfjpe Rnajzku Umlgboqssl Moyrdxe Cpwzfu	Nijmegen	The Netherlands
Elzbuyw Ubicwahhrcvq Mzaduuc Codtuvq Rulderceq (nvekfir Mnw	Rotterdam	The Netherlands
Ujdzdaqwnvdu Mivyfal Clrkuth Gmlrghtyw	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.03.2024

Trial locations

Investigated drugs:

[Al[18F]F]Fapi-74

[18F]F-FAPI is a special imaging agent used in PET-CT scans. It helps doctors find the original location of a cancer when it is not known. This agent works by highlighting areas in the body where cancer cells might be present, making it easier for doctors to see them on the scan.

Carcinoma of Unknown Primary – This is a type of cancer where the primary origin of the tumor is not identified. It is characterized by the presence of metastatic cancer cells in the body, but the location where the cancer began is unknown. The disease often presents with symptoms related to the areas where the cancer has spread, rather than where it started. It can affect various organs and tissues, making it challenging to determine the original site. The progression of the disease depends on the spread and growth of the metastatic tumors. Identifying the primary site can be difficult, and the disease is often diagnosed through exclusion of other known cancers.

Trial ID:

2023-505592-69-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?