Azienda Unita Sanitaria Locale Di Bologna
Bologna, Italy
Recruiting
Study on 68Ga-FAPI-46 PET/CT for Cancer Patients with Unclear Results from 18F-FDG PET/CT
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on patients with cancer who have uncertain or unclear results from a standard imaging test called [18F]F-FDG PET/CT. The study is investigating a new imaging method using a substance called 68Ga-FAPI-46, which is given as a solution for injection. This new method, known as [68Ga]Ga-FAPI PET/CT, aims to provide clearer results for detecting cancer in these patients.
The purpose of the study is to evaluate how well the [68Ga]Ga-FAPI PET/CT can identify the presence of cancer in patients who have already undergone the usual diagnostic procedures but still have uncertain results. The study will compare the accuracy of this new imaging method with the standard [18F]F-FDG PET/CT to see if it can better confirm the presence of cancer.
Participants in the study will receive an injection of 68Ga-FAPI-46 and undergo the [68Ga]Ga-FAPI PET/CT scan. The results will be analyzed to determine if this new method provides more accurate information about the presence of cancer compared to the standard imaging test. The study is expected to continue until June 2025.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Must be at least 18 years old.
- Open to all genders.
- Must have a suspected or newly diagnosed cancer, or have been previously treated for cancer.
- Previous cancer treatments must have been completed at least 3 months ago.
- Must have had a FDG PET/CT scan (a type of imaging test) with unclear results, such as:
- Suspected primary or secondary cancer lesions (like in lymph nodes or distant spread) with absent or low FDG uptake (a measure of how much the cancer cells absorb a special sugar used in the scan).
Who cannot join the trial?
4 criteria
- Patients who are not suspected of having an oncological disease or do not have a new diagnosis of a tumor.
- Patients who have not had a previously treated tumor.
- Patients whose standard clinical or diagnostic tests do not show unclear or uncertain results.
- Patients who do not have a doubtful or inconclusive result from a PET/CT scan using 18F-FDG (a type of imaging test used to look for cancer).
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Investigated drugs
68Ga-FAPI
is a special type of imaging agent used in PET/CT scans. It helps doctors see certain types of cancer more clearly. In this study, it is used to find out if it can better detect cancer in patients who have unclear results from a different type of scan. This agent works by attaching to specific parts of cancer cells, making them visible on the scan.
18F-FDG
is another imaging agent used in PET/CT scans. It is commonly used to detect cancer because it highlights areas of the body that use a lot of sugar, which can indicate the presence of cancer cells. In this study, it is used as a comparison to see if the new agent, 68Ga-FAPI, provides clearer results in cases where the 18F-FDG scan results are uncertain or inconclusive.
What is already known about the treatment
[68Ga]Ga-FAPI – This medication is administered through an injection and is used in a PET/CT scan to help detect cancer in patients who have unclear results from a previous scan. It is currently being studied in clinical trials to determine its effectiveness in identifying cancer when other diagnostic methods are inconclusive. The main use of this medication is to improve the accuracy of cancer detection in patients with uncertain findings. It works by targeting specific proteins in the body that are often found in higher amounts in cancer cells, allowing doctors to see these areas more clearly on the scan. This medication is classified as a radiopharmaceutical, which means it is a radioactive compound used for medical imaging.
Investigated diseases
Oncological Disease – Oncological diseases refer to a broad category of conditions characterized by the uncontrolled growth and spread of abnormal cells. These diseases can originate in any part of the body and may form solid tumors or affect the blood and lymphatic systems. The progression of oncological diseases varies widely depending on the type and location of the cancer, as well as individual patient factors. In general, cancer cells can invade nearby tissues and spread to distant parts of the body through the bloodstream or lymphatic system, a process known as metastasis. The growth rate and pattern of spread can differ significantly among different types of cancer. Early stages may be asymptomatic, while advanced stages can lead to significant organ dysfunction and other complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518765-96-00Protocol codeFAPI-MN-2020Estimated enrolment200 patientsSponsorAzienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
sourced from the EU Clinical Trials Register and site verification
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