Ziv Medical Center
Safed, 13100, Israel
Location status: Recruiting
NCT Number: NCT06792318
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).
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Safed, 13100, Israel
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Ziv Hospital
Other Gov
Use of Fibroblast Activation Protein Inhibitor (FAPI) PET-CT Before Surgery in Patient with Endometriosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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