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The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma

Study acronym: FAPI-PM
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Jan 25, 2025 to Jan 29, 2025v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Seventy (N=70) patients with suspected pleural mesothelioma (PM) lesions referred to pleural biopsy will be recruited, and undergo an additional FAPI PET/CT at primary staging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT). The diagnostic accuracy will be determined with histopathology as reference standard. For patients undergoing anticancer treatment (chemotherapy, immunotherapy, other treatment), an additional FAPI PET/CT and an additional FDG PET/CT will be conducted after the study subjects have completed 2-3 series of anticancer treatment. The feasabilitiy of FAPI PET/CT in response evaluation will be investigated. All study specific analyzes will be blinded and will not influence the patient management / treatment.
Trial Details
NCT Number NCT06790082
Lead Sponsor Aalborg University Hospital
Conditions
(from sponsor)		 Pleural Mesothelioma, Pleural Diseases, Cancer, FAPI, Fibroblast Activation Protein Inhibitor
Related terms Mesothelioma, Malignant, Neoplasms, Pleural Diseases
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov