Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT06792318
Status:
RECRUITING
Last Update Posted:
2025-01-24
First Post:
2025-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of FAPI PET-CT in Diagnosing Endometriosis
Sponsor:
Ziv Hospital
Organization:
Study Overview
Official Title:
Use of Fibroblast Activation Protein Inhibitor (FAPI) PET-CT Before Surgery in Patient with Endometriosis
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRB Number 101-24-ZIV | OTHER | Ziv Medical Center, Safed | View |