18F-DCFPyL PET/CT in High-grade Epithelial Ovarian Cancer (PET HOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03811899|
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : September 26, 2019
The purpose of this study is to determine whether high grade epithelial ovarian cancers (=HG EOC) are 18F-DCFPyL (=2-(3-(1-carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl)-ureido)-pentanedioic acid)-avid and to compare the performance of this PET to CT and findings at time of surgery
There is a need for better noninvasive tools that will map disease extent in HG EOC. A recent study has shown that at immunohistochemistry GCP=II is overexpressed in ovarian cancer tumors, both primary and metastatic. Glucose carboxypeptidase-II (=GCP-II), also known as prostate specific membrane antigen (= PSMA) has been used clinically to assess patients with prostate cancer and many other tumors have been shown to be PSMA-avid on PET (including renal cell carcinomas).
18F-DCFPyL has the potential to improve patient selection for primary therapy. If successful, this may decrease the rate of futile surgeries and associated morbidity and better direct patients to the most appropriate therapy primary debulking surgery (PDS) vs neoadjuvant chemotherapy (NACT). Furthermore, if high-level GCP-II expression is shown at preoperative imaging in patients with HG EOC, this may be used in considering feasibility of future theranostic applications.
This is a single arm pilot study to assess whether HG EOC are 18F-DCFPyL-avid.
In this prospective trial, the investigators will recruit 20 women whom will undergo conventional staging with contrast-enhanced CT of the abdomen and pelvis as per standard of care. All disease sites, primary and metastatic will be recorded using a standardized reporting template.
Subsequently, 18F-DCFPyL-PET/CT will be performed (within 6 weeks of CT).
All disease sites on PET will be recorded using same reporting template in addition to qualitative and semiquantitative evaluation (SUV measurement) of all known tumor sites.
|Condition or disease||Intervention/treatment||Phase|
|Stage III Ovarian Cancer Stage IV Ovarian Cancer||Diagnostic Test: 18F-DCFPyL||Not Applicable|
In patients with ovarian cancer, identifying the volume and exact locations of disease is of paramount importance prior to deciding on upfront surgery versus chemotherapy. Currently, most clinicians use CT scans to determine the extent of disease; however, this tool has limited sensitivity and specificity. 18F-Fluorodeoxyglucose (=FDG) PET scans have been previously assessed with only limited success; therefore, FDG PET scans have not been universally incorporated into the workup of patients with ovarian cancer. A further noninvasive tool that would accurately map disease extent is needed to better select therapy for ovarian cancer patients, reduce the rate of aborted surgery and associated complications, and hopefully improve overall outcome.
"Glutamate carboxypeptidase II (GCP-II)" is a type of an enzyme on the surface of cells. It has additional names including prostate specific membrane antigen (PSMA). It is expressed by normal tissues such as salivary glands, as well as by multiple malignant tumors, often in the abnormal blood vessels of these tumors. A recent study has examined the expression of this enzyme in gynecologic cancers including primary and metastatic ovarian cancer. The authors showed a high expression of this enzyme at special staining performed on surgical tumor samples. In other cancers, such as prostate cancer PET with GCP-II (=PSMA PET) has shown very high sensitivity and high specificity for the detection of tumor sites, even when CT is negative. In this study the investigators will be assessing the performance of this special PET scan using a PSMA tracer called "18F-DCFPyL". The investigators will investigate the ability of 18F-DCFPyL PET scans to detect sites of disease in patients with ovarian cancer. Disease sites seen on PET will be compared to what is seen on the standard CT scan, and to what is found at time of surgery (if surgery is performed).
The rationale for this study is that there is a need for better noninvasive tools that will map disease extent in HG EOC. A recent study has shown that at immunohistochemistry GCP=II is overexpressed in ovarian cancer tumors, both primary and metastatic. GCP-II (=PSMA) has been used clinically to assess patients with prostate cancer and many other tumours have been shown to be PSMA-avid on PET (including renal cell carcinomas). The purpose of this study is to determine whether HG SOC are 18F-DCFPyL (=GCP-II)-avid and to compare the performance of this PET to CT and findings at time of surgery.
To determine whether HG EOCs are 18F-DCFPyL avid on PET/CT.
To compare the sites of disease identified on PET/CT to contrast-enhanced CT (standard of care).
To determine whether there is heterogeneity in 18F-DCFPyL-avidity at different tumor sites.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm study to determine whether HG EOC are 18F-DCFPyL-avid.|
|Masking:||None (Open Label)|
|Official Title:||18F-DCFPyL PET/CT in High-grade Epithelial Ovarian Cancer|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: 18F-DCFPyL PET/CT imaging
We will use technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data is gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre.
Diagnostic Test: 18F-DCFPyL
The purpose of this study is to determine whether HG SOC are 18F-DCFPyL (=GCP-II)-avid and to compare the performance of this PET to CT and findings at time of surgery.
- 18F-DCFPyL-avid PET/CT [ Time Frame: Through study completion up to 2 years ]To determine the proportion of HG EOC that are18F-DCFPyL-avid on PET/CT.
- 18F-DCFPyL PET/CT vs. Contrast-enhanced CT [ Time Frame: Through study completion up to 2 years ]The determine the proportion of HG EOC tumor sites detected on 18F-DCFPyL PET/CT compared to contrast-enhanced CT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811899
|Contact: Ur Metser, MD||416-946-4501 ext email@example.com|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Ur Metser, MD|
|Principal Investigator: Ur Metser, MD|
|Principal Investigator: Liat Hogen, MD|