The Role of FAPI PET-CT in Diagnosing Endometriosis

January 22, 2025 updated by: Israel Sandler, Ziv Hospital

Use of Fibroblast Activation Protein Inhibitor (FAPI) PET-CT Before Surgery in Patient with Endometriosis

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Safed, Israel, 13100
        • Recruiting
        • Ziv Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FAPI PET-CT Diagnostic Arm
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of FAPI PET-CT in Endometriosis Detection
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.
Within 1 month post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of FAPI PET-CT with Conventional Imaging
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.
Within 1 month post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101-24-ZIV
  • IRB Number 101-24-ZIV (Other Identifier: Ziv Medical Center, Safed)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Start: "9 months after publication" End: "36 months following publication"

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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