Study on [68Ga]FAPI-46 PET Scans for Patients with Pancreatic Ductal Cancer

Sponsor: SOFIE

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05262855

Provider View

This clinical trial is testing a new imaging method using [68Ga]FAPI-46 PET scans to detect specific cells in patients with pancreatic ductal cancer that can be surgically removed or is borderline removable. The study involves two scans, one before and one after any pre-surgery treatments, to compare with the actual tumor after surgery.

Patient Parameters

Program Overview

The study aims to evaluate how well [68Ga]FAPI-46 PET scans can identify certain cells in patients with pancreatic ductal adenocarcinoma (PDAC) that can be surgically removed or are borderline removable. Participants will undergo a PET scan after their initial cancer staging. If they receive treatments like chemotherapy or radiation before surgery, a second PET scan will be done within 21 days before the planned surgery. The results of these scans will be compared with the tumor tissue removed during surgery to see how accurately the scans detect cancer cells.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with pancreatic ductal adenocarcinoma.
  • Have not received any treatment yet.
  • Cancer is considered removable by surgery or borderline removable.
  • Plan to have surgery or receive treatments like chemotherapy or radiation before possible surgery.
  • Recent imaging tests like CT or MRI done within 28 days before joining the study.
  • At least 18 years old.
  • Have signed an informed consent form.

Exclusion Criteria

  • Pregnant individuals, as confirmed by a pregnancy test.
  • Not willing to use effective birth control during the study if they can have children.
  • Require urgent surgery that cannot be delayed.
  • Have infections needing treatment with medication.
  • Have serious health conditions that could affect safety or study results, like kidney or liver failure.
  • Have autoimmune disorders.
  • Have taken any experimental drugs in the last 28 days.
  • Breastfeeding, unless willing to pump and discard breast milk for 24 hours after the [68Ga]FAPI-46 injection.
  • Allergic to any ingredients in [68Ga]FAPI-46, such as sodium acetate or hydrochloric acid.

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