Use of Fibroblast Activation Protein Inhibitor (FAPI) PET-CT Before Surgery in Patient with Endometriosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Diagnostic Accuracy of FAPI PET-CT in Endometriosis Detection
Study Overview
Brief Summary
Patients with suspected endometriosis scheduled for surgery will be identified. They will be asked to participate in a study evaluating the feasibility of FAPI PET-CT in diagnosing endometriosis. The results will be compared with surgical findings, pathology, and other imaging techniques if available (i.e., MRI, US).
Detailed Description
This study investigates FAPI PET-CT imaging in endometriosis diagnosis using a standardized protocol. Participants will undergo two imaging sessions after a single FAPI injection:
First Session:
Initial scan at 10 minutes post-injection Follow-up scan at 30 minutes
Second Session:
Additional scans at 60 and 80 minutes post-injection
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
Open label study. The surgeon operates based on PET-CT findings, and the pathologist examines specimens from lesions detected on PET-CT
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female participants aged 18-45 years
- •Clinical suspicion of endometriosis based on symptoms
- •Scheduled for diagnostic/therapeutic laparoscopic surgery
- •Ability to understand and provide written informed consent
- •Completed and signed Radiation Exposure Documentation Form
Exclusion Criteria
- •Pregnant women or women who are breastfeeding
- •History of pelvic radiation therapy
- •Known active malignancy
- •Exposure to ionizing radiation for medical purposes within 12 months prior to enrollment
Arms & Interventions
FAPI PET-CT Diagnostic Arm
Participants undergo FAPI PET-CT imaging at multiple timepoints (10, 30, 60, and 80 minutes post-injection) using a single FAPI dose. Each participant will then undergo laparoscopic surgery with tissue sampling for pathological confirmation of endometriotic lesions.
Intervention: FAPI PET-CT (Diagnostic Test)
Outcomes
Primary Outcomes
Diagnostic Accuracy of FAPI PET-CT in Endometriosis Detection
Time Frame: Within 1 month post-surgery
Assessment of FAPI PET-CT diagnostic performance through calculation of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Surgical findings with histological confirmation will serve as the reference standard for evaluation.
Secondary Outcomes
- Comparison of FAPI PET-CT with Conventional Imaging(Within 1 month post-surgery)
Investigators
Israel Sandler
MD
Ziv Medical Center