The Role of FAPI PET-CT in Diagnosing Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2027-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of a New Diagnostic Tool in the Detection and Characterization of Endometriosis Lesions

NCT07053982

Endometriosis

NOT_YET_RECRUITING NA

Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

NCT04382911

Endometriosis

COMPLETED PHASE2

PET/MRI for Evaluation of Endometriosis

NCT06377553

Endometriosis Endometrioma

ENROLLING_BY_INVITATION

Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat

NCT02973854

Endometriosis

COMPLETED

Feasibility Study of Using Molecular Fluorescence Guided Surgery in Endometriosis

NCT02975219

Endometriosis

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Open label study. The surgeon operates based on PET-CT findings, and the pathologist examines specimens from lesions detected on PET-CT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

FAPI PET-CT

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No