Clinical trial NCT06792318: The Role of FAPI PET-CT in Diagnosing Endometriosis
Official title: Use of Fibroblast Activation Protein Inhibitor (FAPI) PET-CT Before Surgery in Patient with Endometriosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: endometriosis
PET CT
Fibroblast activation protein inhibitor
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy of FAPI PET-CT in Endometriosis Detection
timeFrame: Within 1 month post-surgery
Secondary outcomes:
measure: Comparison of FAPI PET-CT with Conventional Imaging
timeFrame: Within 1 month post-surgery
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
References:
citation: Zhao L, Kang F, Pang Y, Fang J, Sun L, Wu H, Lan X, Wang J, Chen H. Fibroblast Activation Protein Inhibitor Tracers and Their Preclinical, Translational, and Clinical Status in China. J Nucl Med. 2024 May 6;65(Suppl 1):4S-11S. doi: 10.2967/jnumed.123.266983.
citation: Fox R, Chang S, Hicks L, Mooney S, Rogers PAW, Hicks RJ, Tyson K, Holdsworth-Carson SJ. Positron emission tomography in the evaluation of endometriosis: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2024 Aug;299:258-265. doi: 10.1016/j.ejogrb.2024.06.017. Epub 2024 Jun 12.
citation: Garcia Garcia JM, Vannuzzi V, Donati C, Bernacchioni C, Bruni P, Petraglia F. Endometriosis: Cellular and Molecular Mechanisms Leading to Fibrosis. Reprod Sci. 2023 May;30(5):1453-1461. doi: 10.1007/s43032-022-01083-x. Epub 2022 Oct 26.
citation: Pascoal E, Wessels JM, Aas-Eng MK, Abrao MS, Condous G, Jurkovic D, Espada M, Exacoustos C, Ferrero S, Guerriero S, Hudelist G, Malzoni M, Reid S, Tang S, Tomassetti C, Singh SS, Van den Bosch T, Leonardi M. Strengths and limitations of diagnostic tools for endometriosis and relevance in diagnostic test accuracy research. Ultrasound Obstet Gynecol. 2022 Sep;60(3):309-327. doi: 10.1002/uog.24892.
citation: Parasar P, Ozcan P, Terry KL. Endometriosis: Epidemiology, Diagnosis and Clinical Management. Curr Obstet Gynecol Rep. 2017 Mar;6(1):34-41. doi: 10.1007/s13669-017-0187-1. Epub 2017 Jan 27.