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| ID | Type | Description | Link |
|---|---|---|---|
| IRB Number 101-24-ZIV | Other Identifier | Ziv Medical Center, Safed |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAPI PET-CT Diagnostic Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAPI PET-CT | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of FAPI PET-CT in Endometriosis Detection | 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. | Within 1 month post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of FAPI PET-CT with Conventional Imaging | 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. | Within 1 month post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Israel Sandler, MD | Contact | +972-527-362280 | israels@ziv.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziv Medical Center | Recruiting | Safed | 13100 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38719234 | Background | 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. | |
| 38917749 | Background | 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. |
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Individual participant data (IPD) that underlie the results reported in published articles will be shared after deidentification. Data will be available beginning 9 months and ending 36 months following article publication. Data will be shared with researchers who provide a methodologically sound scientific proposal. Proposals should be directed to [israels@ziv.gov.il]. Data requestors will need to sign a data access agreement. Data will include deidentified participant data related to FAPI PET-CT findings and surgical/pathological outcomes.
Start: "9 months after publication" End: "36 months following publication"
Qualified researchers can submit a proposal to access de-identified IPD and supporting documents. The proposal should include: research objectives, statistical analysis plan, research team qualifications, and funding source. Upon approval, researchers must sign a data access agreement. Data will be shared via a secure institutional platform.
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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Open label study. The surgeon operates based on PET-CT findings, and the pathologist examines specimens from lesions detected on PET-CT
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| 36289173 | Background | 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. |
| 35229963 | Background | 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. |
| 29276652 | Background | 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. |
| D000091662 | Genital Diseases |