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NCT Number: NCT06792318

The Role of FAPI PET-CT in Diagnosing 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).

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Israel Sandler, MD

CONTACT

[email protected]

+972-527-362280

Sponsors and collaborators

Lead sponsor

Ziv Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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