Prospective Trial of [18F]AlF-FAPI-74 for PET Imaging of Fibroblast Activation Protein in Patients With Endometriosis

Study acronym: EM-FAPI
StatusRecruiting
PhaseNot applicable
Started

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Record History

  1. Recruitment opened
    • Site details revised
  2. Study First Submitted
  • 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.
The goal of this clinical trial is to learn whether \[18F\]AlF-FAPI-74 PET/CT can help detect endometriosis in adult women who are already scheduled for laparoscopy due to suspicion of deep infiltrating endometriosis or superficial peritoneal endometriosis. The main aims are: (i) How well does \[18F\]AlF-FAPI-74 PET/CT identify endometriosis lesions compared with findings during laparoscopy? (ii) Can PET/CT identify additional lesions that may not be seen on ultrasound or MRI? (iii) Can ultra-high-resolution NeuroEXPLORER PET/CT improve the detection of small lesions compared with standard PET/CT? Participants will: (i) Receive an intravenous injection of \[18F\]AlF-FAPI-74 followed by a PET/CT scan before their planned laparoscopy. (ii) Undergo their planned laparoscopy, during which PET findings will be compared with the surgical findings and where tissue is removed with laboratory analysis. (iii) Optionally undergo an additional NeuroEXPLORER PET/CT scan after the same tracer injection. (iv) Optionally undergo a second \[18F\]AlF-FAPI-74 PET/CT if participants started gonadotropin-releasing hormone (GnRH) treatment after their first scan to investigate whether tracer uptake in endometriosis lesions changes during treatment.
Trial Details
NCT Number NCT07876648
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Conditions
(from sponsor)		 Endometriosis, Deep Infiltrating Endometriosis, Women, Superficial Peritoneal Endometriosis, Fibrosis
Related terms Endometriosis, Fibrosis
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov