NCT06792318

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Mar 2025Jun 2027

First Submitted

Initial submission to the registry

January 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

January 15, 2025

Last Update Submit

January 22, 2025

Conditions

Endometriosis

Keywords

endometriosisPET CTFibroblast activation protein inhibitor

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Comparison of FAPI PET-CT with Conventional Imaging

    Within 1 month post-surgery

Study Arms (1)

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.

Diagnostic Test: FAPI PET-CT

Interventions

FAPI PET-CTDIAGNOSTIC_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

FAPI PET-CT Diagnostic Arm

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Medical Center

Safed, 13100, Israel

RECRUITING

Related Publications (5)

  • 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: 38719234BACKGROUND

  • 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: 38917749BACKGROUND

  • 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: 36289173BACKGROUND

  • 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: 35229963BACKGROUND

  • 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: 29276652BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Israel Sandler, MD

CONTACT

+972-527-362280israels@ziv.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open label study. The surgeon operates based on PET-CT findings, and the pathologist examines specimens from lesions detected on PET-CT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 24, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Start: "9 months after publication" End: "36 months following publication"
Access Criteria
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.

Locations

IL(1)