Endometriosis
Conditions
Keywords
endometriosis, PET CT, Fibroblast activation protein inhibitor
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 The protocol is designed to minimize radiation exposure through: Single FAPI injection Two ultra-low dose CT scans Limited field of view to suspected areas. Nuclear medicine physicians will review PET-CT images independently, blinded to other imaging findings (MRI, US). Results will be shared with surgeons to guide the removal of suspicious lesions during surgery. All removed tissue will undergo pathological examination for confirmation. The study incorporates safety monitoring: Observation during and after FAPI administration Follow-up contact at 24-48 hours post-scan Documentation of any adverse events Immediate reporting of unexpected findings. This research could potentially provide evidence for a novel, non-invasive method to comprehensively map endometriotic lesions, improving pre-operative planning.
Interventions
DIAGNOSTIC_TESTFAPI PET-CT
FAPI PET-CT imaging protocol: Single dose 68Ga/18F-FAPI (2 MBq/kg) Two imaging sessions: First: 10 and 30 minutes post-injection Second: 60 and 80 minutes post-injection Ultra-low dose CT for attenuation correction and anatomical localization
Sponsors
Ziv Hospital
Study design
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
Intervention model description
All participants undergo FAPI PET-CT imaging followed by laparoscopic surgery. Surgical specimens are sent for pathological confirmation of PET-CT findings. This single-group diagnostic study aims to evaluate the accuracy of FAPI PET-CT in detecting endometriosis lesions using surgical and pathological findings as the gold standard.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of FAPI PET-CT in Endometriosis Detection | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of FAPI PET-CT with Conventional Imaging | Within 1 month post-surgery | Evaluation of FAPI PET-CT's ability to detect endometriotic lesions not visible on conventional imaging (TVUS and MRI). Comparison includes identification of additional lesions and assessment of anatomical distribution of detected lesions. |
Countries
Israel
Contacts
Primary ContactIsrael Sandler, MD
Outcome results
None listed