The Role of FAPI PET-CT in Diagnosing Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FAPI PET-CT.
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of Fibroblast Activation Protein Inhibitor (FAPI) PET-CT Before Surgery in Patient with Endometriosis
Overview
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 test FAPI 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
Primary outcome measures
- Diagnostic Accuracy of FAPI PET-CT in Endometriosis Detection [Time frame: Within 1 month post-surgery]
Secondary outcome measures (1)
- Comparison of FAPI PET-CT with Conventional Imaging [Time frame: Within 1 month post-surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Israel · 1 center
- Ziv Medical Center — Safed
Publications
- 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. PMID 38719234
- 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. PMID 38917749
- 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. PMID 36289173
- 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. PMID 35229963
- 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. PMID 29276652
Identifiers
NCT: NCT06792318 · 101-24-ZIV · IRB Number 101-24-ZIV