Clinical Trial for Gastric and Esophageal Cancer Metastasis Detection

Strategic Insights -

Researchers are investigating the diagnostic performance of [àü¹F]FAPI-74 PET/CT in detecting metastatic disease in adults with gastric or esophageal cancer. A Phase 3 clinical trial, sponsored by SOFIE, aims to enroll 200 participants from the USA to assess the clinical utility of this imaging modality. The trial will evaluate the sensitivity and specificity of [àü¹F]FAPI-74 PET/CT using a composite SOT panel, with participants undergoing imaging and follow-up procedures for up to 3 months.

Key Takeaways:

  • The trial, listed on ClinicalTrials.gov, is a Phase 3, multi-site, open-label, non-randomized study with a maximum expected duration of approximately 24 months.
  • The study aims to assess the diagnostic performance of [àü¹F]FAPI-74 PET/CT in detecting metastatic disease in adults with gastric or esophageal cancer.
  • The trial will enroll 200 participants from the USA, with participants undergoing imaging and follow-up procedures for up to 3 months.
  • The primary objective is to evaluate the sensitivity and specificity of [àü¹F]FAPI-74 PET/CT using a composite SOT panel.
  • The trial will assess the clinical utility of [àü¹F]FAPI-74 PET/CT, with results potentially informing treatment decisions for patients with gastric or esophageal cancer.

Statistics:

  • The trial is expected to last approximately 24 months from first patient screening to last patient SOC follow up.
  • Participants will be followed-up for safety for 24 to 72 hours after the dose of [àü¹F]FAPI-74 PET/CT.
  • The trial will enroll 200 participants from the USA.
  • The imaging modality being studied is [àü¹F]FAPI-74 PET/CT.

Sources:

  • ClinicalTrials.gov
  • SOFIE
  • [àü¹F]FAPI-74 PET/CT
  • SOFIE is not specified as a primary source, but rather mentions the trial on ClinicalTrials.gov as the sponsor.