Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID06792318

Use of Fibroblast Activation Protein Inhibitor (FAPI) PET-CT Before Surgery in Patients with Endometriosis to Evaluate Diagnostic Accuracy

Led by Ziv Hospital · Updated on 2025-01-24

30

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of FAPI PET-CT imaging to diagnose endometriosis in women suspected of having this condition and scheduled for surgery. The study aims to assess how well FAPI PET-CT compares with surgical findings, pathology results, and other imaging methods like MRI and ultrasound. This research may offer a new, non-invasive way to better identify endometriotic lesions before surgery. Participants will receive a single injection of 68Ga/18F-FAPI at a dose of 2 MBq/kg followed by two imaging sessions. The first session includes scans at 10 and 30 minutes after injection, and the second session includes scans at 60 and 80 minutes post-injection. Ultra-low dose CT scans will be performed for anatomical reference and to minimize radiation exposure. Nuclear medicine specialists will review the PET-CT images without knowledge of other imaging findings and share results with surgeons to guide lesion removal during laparoscopy. During the study, participants will be observed during and after the FAPI injection, and follow-up contact will be made 24 to 48 hours after imaging to monitor safety and record any side effects. All surgically removed tissue will be examined pathologically to confirm diagnosis. The main outcome measured is how accurately the FAPI PET-CT detects endometriosis within one month after surgery, with the total involvement lasting through surgery and follow-up assessments.

CONDITIONS

Official Title

The Role of FAPI PET-CT in Diagnosing Endometriosis

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 18-45 years
  • Clinical suspicion of endometriosis based on symptoms
  • Scheduled for diagnostic or therapeutic laparoscopic surgery
  • Ability to understand and provide written informed consent
  • Completed and signed Radiation Exposure Documentation Form
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ziv Medical Center

Safed, Israel, 13100

Actively Recruiting

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Research Team

I

Israel Sandler, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial