68Ga-FAPI-46 in Staging of Pancreatic Adenocarcinoma

NCT06911021 | Not Yet Recruiting

• 1 other identifier: FAPI-PANC-2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Adenocarcinoma; PET / CT; FAPI; Surgical Oncology; Molecular Imaging

Keywords

Novel imaging in pancreatic cancer; Fibroblast activation protein imaging; Cancer-associated fibroblasts; PET/CT and pancreatic tumor; Tumor microenvironment imaging

Outcome Measures

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.

  From PET/CT scan up to 30 days after surgery

Secondary Outcomes (4)

• Detection of Cancer in Lymph Nodes Using 68Ga-FAPI-46 PET/CT

  From scan to histological analysis of surgical specimens (up to 30 days after surgery)

• Identification of Tumor Infiltration in Surgical Tissue Samples

  From scan to histological analysis of surgical specimens (up to 30 days after surgery)

• Impact of FAPI PET/CT on Surgical and Treatment Planning

  From PET to surgery (up to 30 days)

• Safety of 68Ga-FAPI-46 PET/CT

  From injection to follow-up call (3-5 days after scan)

Study Arms (1)

68Ga-FAPI-46 PET/CT Imaging Group

EXPERIMENTAL

Single group receiving 68Ga-FAPI-46 PET/CT for diagnostic imaging prior to pancreatic cancer surgery

Diagnostic Test: 68Ga-FAPI-46 PET/CT

Interventions

68Ga-FAPI-46 PET/CT DIAGNOSTIC_TEST

A 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.

68Ga-FAPI-46 PET/CT Imaging Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Karnofsky index ≥80%.
• Operable or operable borderline tumor after neoadjuvant chemotherapy response
• Planned surgical tumor resection.
• SOC imaging (ceCT and MRI) performed as pre-surgery exams.
• Signed informed consent.

You may not qualify if:

• Pregnancy or breastfeeding.
• Claustrophobia.
• Severe renal insufficiency (GFR\<30 mL/min/1.73m²).
• Liver enzymes (ALAT, ASAT \>5× the upper limit).
• Bilirubin \>3× the upper limit.
• Hemoglobin \<8 g/dL.
• Absolute neutrophil count \<1000/mm³.
• Platelets \<75,000/µL.
• Inability to give informed consent or follow study procedures.
• The patient refuses to receive information regarding incidental findings.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Giulia Piazza, MD

CONTACT

+41795563219; giulia.piazza@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)