AzTrials
AzTrials

EndometriosisNCT06792318

The Role of FAPI PET-CT in Diagnosing Endometriosis

A study testing FAPI PET-CT in people with Endometriosis, run by Ziv Hospital at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometriosis
What is being tested?
FAPI PET-CT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIsrael
Study dates
Mar 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Israel Sandler, MD contact

+972-527-362280

israels@ziv.gov.il

Israel1 site, 1 recruiting

  • Ziv Medical Center

    Safed, 13100

    Israel Sandler, MD, +972-527362280, israels@ziv.gov.il

    Recruiting

Other trials in Israel

About this study

Official title: 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).

Read the 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.

Conditions
Endometriosis
Being tested
FAPI PET-CT
Keywords
endometriosis, PET CT, Fibroblast activation protein inhibitor
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT06792318
Study groupRoleWhat they receive
FAPI PET-CT Diagnostic ArmExperimentalParticipants 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.
Receives: Diagnostic Test: FAPI PET-CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 1 month post-surgery

Secondary outcomes (1)

  1. Comparison of FAPI PET-CT with Conventional Imaging

    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.

    Measured: Within 1 month post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study startMar 2025 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06792318
Sponsor's protocol ID
101-24-ZIV
Other IDs
IRB Number 101-24-ZIV
Status last verified
Jan 2025
First submitted
15 Jan 2025
Last updated
24 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 38719234

  • 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.

    PubMed 38917749

  • 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.

    PubMed 36289173

  • 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.

    PubMed 35229963

  • 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.

    PubMed 29276652

Questions about this trial

What is this clinical trial studying?

A study testing FAPI PET-CT in people with Endometriosis, run by Ziv Hospital at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Israel Sandler, MD (+972-527-362280, israels@ziv.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Accuracy of FAPI PET-CT in Endometriosis Detection (time frame: Within 1 month post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06792318, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in