68Ga-FAPI-46 in Staging of Pancreatic Adenocarcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Vaudois
About this trial
This clinical study investigates the use of a new imaging technique called 68Ga-FAPI-46 PET/CT in people with pancreatic ductal adenocarcinoma (PDAC), a type of cancer known for its rapid progression, late diagnosis, and poor survival rate. One of the main challenges with pancreatic cancer is that standard images like MRI and CT, while helpful, are not always able to clearly show how far the cancer has spread or where exactly the tumor ends. This can make surgery and treatment planning more difficult and less precise.
The new image technique being studied, 68Ga-FAPI-46 PET/CT, works by injecting a small and safe amount of a radioactive substance into a vein. This substance travels through the body and attaches to a specific protein called FAP, which is found in large amounts in the tissue that surrounds many pancreatic tumors. By sticking to this protein, the tracer highlights not only the tumor but also the surrounding area that may be affected by the cancer. This results in very detailed images that may show the tumor more clearly than other techniques.
Each participant in the study will receive a single injection of the tracer, and about an hour later they will have the PET/CT scan. The scan itself is quick, painless, and non-invasive, and takes about 20 minutes. A few days later, participants will receive a follow-up phone call to check if they experienced any side effects, though previous studies with over 1,000 people have shown the tracer to be very safe.
The purpose of the study is to find out whether this new technique provides more useful and accurate information than the standard images currently used. It may help better detect the size of the tumor, see if it has spread to other parts of the body, and give doctors a clearer idea of how to plan surgery. This could make it easier to remove the tumor completely and choose the most effective treatment for each patient.
This pilot study is being conducted at Lausanne University Hospital (CHUV) with 20 adult participants over two years. CHUV is the first hospital in Switzerland to offer this kind of scan. If the study is successful, this scan may become a regular part of care for people with pancreatic cancer and could also be used in other cancers in the future.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Karnofsky index ≥80%.
Operable or operable borderline tumor after neoadjuvant chemotherapy response
Planned surgical tumor resection.
Disqualifiers
Pregnancy or breastfeeding.
Claustrophobia.
Severe renal insufficiency (GFR<30 mL/min/1.73m²).
Liver enzymes (ALAT, ASAT >5× the upper limit).
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-FAPI-46 PET/CT
Diagnostic testA single-dose intravenous injection of the radiotracer 68Ga-FAPI-46 will be administered to participants. Approximately 60 minutes after injection, a whole-body PET/CT scan will be performed. The scan is designed to detect areas of high fibroblast activation protein (FAP) expression in and around pancreatic tumors, providing high-resolution images of tumor margins and potential spread. The goal is to evaluate whether this imaging method offers more accurate and useful information than standard imaging (MRI and CT) for preoperative staging and surgical planning.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: 68Ga-FAPI-46 PET/CT Imaging GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Accuracy of 68Ga-FAPI-46 PET/CT in Identifying Tumor Size and Spread Before Surgery
This outcome will assess how well the 68Ga-FAPI-46 PET/CT scan identifies the size of the primary tumor, its exact borders, and whether it has spread to nearby lymph nodes or other parts of the body, compared to standard imaging methods (MRI and CT). The results will be checked against what is found in the tissue removed during surgery (the gold standard). This will help determine if the new scan provides more precise and useful information for surgical planning and staging.
Time frame
From PET/CT scan up to 30 days after surgerySecondary outcomes
1
Detection of Cancer in Lymph Nodes Using 68Ga-FAPI-46 PET/CT
This outcome will evaluate whether the 68Ga-FAPI-46 PET/CT scan can accurately show if the cancer has spread to nearby lymph nodes. The results of the scan will be compared with what is found in the lymph nodes removed during surgery.
Time frame
From scan to histological analysis of surgical specimens (up to 30 days after surgery)2
Identification of Tumor Infiltration in Surgical Tissue Samples
This outcome will assess if the FAPI PET/CT scan can correctly show where the cancer has invaded tissues that are later removed during surgery. Scan results will be matched with microscopic analysis of those tissues.
Time frame
From scan to histological analysis of surgical specimens (up to 30 days after surgery)3
Impact of FAPI PET/CT on Surgical and Treatment Planning
This outcome will evaluate whether the scan influences how surgery or treatment is planned. The research team will review whether the information from the scan led to changes in the medical team's decisions, such as modifying the surgery or choosing additional treatments.
Time frame
From PET to surgery (up to 30 days)4
Safety of 68Ga-FAPI-46 PET/CT
This outcome will track any side effects or safety concerns that occur after the 68Ga-FAPI-46 injection and scan. Patients will be monitored by phone and during follow-up visits, and safety will be evaluated using standard clinical criteria.
Time frame
From injection to follow-up call (3-5 days after scan)Sponsors and contacts
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Source ClinicalTrials.gov
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