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Search / Trial NCT06911021

68Ga-FAPI-46 in Staging of Pancreatic Adenocarcinoma

Launched by CENTRE HOSPITALIER UNIVERSITAIRE VAUDOIS · Mar 28, 2025

Trial Information

Current as of May 30, 2025

Not yet recruiting

Keywords

Novel Imaging In Pancreatic Cancer Fibroblast Activation Protein Imaging Cancer Associated Fibroblasts Pet/Ct And Pancreatic Tumor Tumor Microenvironment Imaging

ClinConnect Summary

This clinical trial is exploring a new imaging technique called 68Ga-FAPI-46 PET/CT to help doctors better understand pancreatic cancer, specifically pancreatic ductal adenocarcinoma (PDAC). Traditional imaging methods like MRI and CT scans can sometimes miss important details about how far the cancer has spread or the exact size of the tumor, making it harder to plan effective treatments or surgeries. The 68Ga-FAPI-46 PET/CT scan works by injecting a small, safe amount of a radioactive substance that targets a specific protein found in the tissues around many pancreatic tumors. This allows for clearer images, which may help doctors better see the tumor and its surroundings.

Adults aged 18 and older who have been diagnosed with an operable pancreatic tumor and are planning to have surgery may qualify for this study. Participants will receive a single injection of the tracer and then undergo a quick, painless scan about an hour later. The entire process is non-invasive and lasts around 20 minutes. After the scan, researchers will check in to see if there are any side effects, but this technique has been shown to be very safe in previous studies. This trial is taking place at Lausanne University Hospital in Switzerland, and if successful, it could lead to this imaging method becoming a regular part of care for pancreatic cancer and potentially other cancers in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.

About Centre Hospitalier Universitaire Vaudois

The Centre Hospitalier Universitaire Vaudois (CHUV) is a leading academic medical center located in Lausanne, Switzerland, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, CHUV plays a pivotal role in translating scientific discoveries into transformative therapies, enhancing patient care across a diverse range of medical disciplines. With a multidisciplinary team of experts and state-of-the-art facilities, CHUV is dedicated to fostering collaboration and delivering high-quality evidence that informs clinical practice and policy.

Locations

Lausanne, Vaud, Switzerland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported