Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377553
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
PETMRI for Evaluation of Endometriosis
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
PETMRI Evaluation of Endometriosis Using Intercellular Matrix Radiopharmaceuticals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
This study aims to determine if PETMRI can detect endometriosis and potentially improve upon currently available non-invasive diagnostic capabilities Specifically the authors will investigate the ability of PETMRI to detect and quantify endometriosis as well as differentiate among subcategories such as inflammatory peritoneal lesions fibrotic deep infiltrating endometriosis lesions DIE and ovarian endometriomas The authors will compare 68GaCBP8 or 18F-FAPI-74 PETMRI imaging versus the current gold standard diagnostic methods including laparoscopic surgery clinical follow-up and follow-up imaging
Detailed Description:
Several imaging techniques including ultrasound computed tomography and magnetic resonance imaging MRI have been used for the detection of DIE for mapping and staging endometriosis Currently the modalities most commonly used are transvaginal ultrasound TVS and magnetic resonance imaging MRI TVS is generally considered a first-line techniqueTVS in highly experienced hands meets the criteria for mapping DIE to the uterosacral ligaments rectovaginal septum vaginal wall pouch of Douglas and rectosigmoid however it is limited by its operator dependance and by the small field of view FOV MRI is commonly used for mapping lesions within the Douglas pouch and rectovaginal septum and rectosigmoid MRI has shown acceptable diagnostic values with pooled sensitivity and specificity for pelvic endometriosis of 94 and 77 respectively For rectosigmoid endometriosis MRIs pooled sensitivity and specificity were 92 and 96 respectively However MRI has limitations specially in the evaluation of chronic fibrotic endometriosis and for assessing the peritoneum and extension beyond the pelvis as well as DIEs There is a growing body of literature examining the role of PETMRI in pelvic and abdominal malignancies and its potential superiority to MRI alone However there are no studies that used PETMRI to investigate endometriosis
This study aims to use 68GaCBP8- or 18FFAPI PETMRI to diagnose and quantify endometriosis The novel radiopharmaceutical collagen-binding probe 8 labeled with Gallium-68 selectively binds to collagen type I the predominant extracellular protein in fibrosis 68GaCBP8 has already been investigated in patients affected by pulmonary fibrosis with success Fibroblast activation protein FAP is a type II transmembrane serine protease that is overexpressed in CAFs and to a lesser extent in benign processes It is associated with extracellular matrix remodeling for example chronic inflammation degenerative bone and spine disease arthritis and cardiac remodelling after myocardial infarction Quinolone-based FAP inhibitors FAPIs constitute a class of molecules with high affinity to FAP deployed to assess many types of solid tumors and some benign pathologies 68Ga-FAPIs and to a lesser extent 18F-FAPI are being extensively studied in oncologic and non-oncologic positron emission tomographycomputed tomography PETCT and to a lesser extent PETMRI both in Europe and Asia
In this single-arm single-center open label prospective study the authors will recruit 60 patients with clinical diagnosis of endometriosis who candidate for laparoscopic surgery Patients will be referred to FAPI- or CBP8-PETMRI by their primary treating gynecologist physicians Laparoscopy will serve as primary standard of reference clinical and imaging follow up as well as prior diagnostic imaging studies CT MRI US will serve as secondary standard of reference In the case patients will not undergo laparoscopy then clinical and imaging follow up as well as prior diagnostic imaging studies CT MRI US will serve as primary standard of reference
Board-certified radiologists will evaluate 18F-FAPI-74 or 68GaCBP8-PETMR images and standalone MR images in a blinded fashion on separate occasions Assessment of of endometriosis will be performed according to consolidated published criteria for MRI For endometriosis staging the readers will follow rASRM criteria Then the authors will compare the sensitivity specificity and accuracy of regionalwhole-body staging using FAPIor CBP-PETMRI versus regionalwholebody MRI with the standard reference set as pathology results when available or clinical and imaging follow-up otherwise Hypothesis testing will be performed using McNemars test for matched pairs testing
This study aims to use 68GaCBP8- or 18FFAPI PETMRI to diagnose and quantify endometriosis The novel radiopharmaceutical collagen-binding probe 8 labeled with Gallium-68 selectively binds to collagen type I the predominant extracellular protein in fibrosis 68GaCBP8 has already been investigated in patients affected by pulmonary fibrosis with success Fibroblast activation protein FAP is a type II transmembrane serine protease that is overexpressed in CAFs and to a lesser extent in benign processes It is associated with extracellular matrix remodeling for example chronic inflammation degenerative bone and spine disease arthritis and cardiac remodelling after myocardial infarction Quinolone-based FAP inhibitors FAPIs constitute a class of molecules with high affinity to FAP deployed to assess many types of solid tumors and some benign pathologies 68Ga-FAPIs and to a lesser extent 18F-FAPI are being extensively studied in oncologic and non-oncologic positron emission tomographycomputed tomography PETCT and to a lesser extent PETMRI both in Europe and Asia
In this single-arm single-center open label prospective study the authors will recruit 60 patients with clinical diagnosis of endometriosis who candidate for laparoscopic surgery Patients will be referred to FAPI- or CBP8-PETMRI by their primary treating gynecologist physicians Laparoscopy will serve as primary standard of reference clinical and imaging follow up as well as prior diagnostic imaging studies CT MRI US will serve as secondary standard of reference In the case patients will not undergo laparoscopy then clinical and imaging follow up as well as prior diagnostic imaging studies CT MRI US will serve as primary standard of reference
Board-certified radiologists will evaluate 18F-FAPI-74 or 68GaCBP8-PETMR images and standalone MR images in a blinded fashion on separate occasions Assessment of of endometriosis will be performed according to consolidated published criteria for MRI For endometriosis staging the readers will follow rASRM criteria Then the authors will compare the sensitivity specificity and accuracy of regionalwhole-body staging using FAPIor CBP-PETMRI versus regionalwholebody MRI with the standard reference set as pathology results when available or clinical and imaging follow-up otherwise Hypothesis testing will be performed using McNemars test for matched pairs testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None