Stage III Ovarian CancerNCT03811899
18F-DCFPyL PET/CT in High-grade Epithelial Ovarian Cancer (PET HOC)
A study testing 18F-DCFPyL in people with Stage III Ovarian Cancer and Stage IV Ovarian Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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 Background: There is… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage III Ovarian Cancer, Stage IV Ovarian Cancer
- What is being tested?
- 18F-DCFPyL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 13 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Cytological or histological diagnosis of high grade epithelial ovarian cancer, or clinical suspicious of HG EOC based on symptoms, physical exam, tumor markers and imaging findings.
- Clinical stage III or IV, being considered for primary debulking surgery or NACT.
- Contrast-enhanced CT abdomen and pelvis within 6 weeks of PET (prior to enrollment).
Who cannot join
- Inability to provide informed consent.
- Contraindication for PET examination as per institutional safety guidelines, including but not limited to pregnancy, or inability to lie still for PET examination.
- Evidence of the following epithelial ovarian cancer histological subtypes: Mucinous, low grade serous, low grade endometrioid and low-malignant potential tumors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 18F-DCFPyL PET/CT in High-grade Epithelial Ovarian Cancer
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
Background:
Read more
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.
Study Design:
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.
Read the detailed description
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.
Primary Objective
To determine whether HG EOCs are 18F-DCFPyL avid on PET/CT.
Secondary Objectives:
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.
- Conditions
- Stage III Ovarian Cancer, Stage IV Ovarian Cancer
- Being tested
- 18F-DCFPyL
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DCFPyLDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 18F-DCFPyL PET/CT imaging | Experimental | 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. Receives: Diagnostic Test: 18F-DCFPyL |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-DCFPyL-avid PET/CT
To determine the proportion of HG EOC that are18F-DCFPyL-avid on PET/CT.
Measured: Through study completion up to 2 years
Secondary outcomes (1)
18F-DCFPyL PET/CT vs. Contrast-enhanced CT
The determine the proportion of HG EOC tumor sites detected on 18F-DCFPyL PET/CT compared to contrast-enhanced CT
Measured: Through study completion up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Apr 2019
- Primary completion30 Jun 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stage III Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single arm study to determine whether HG EOC are 18F-DCFPyL-avid.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ur Metser, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811899
- Sponsor's protocol ID
- 18-6241
- Status last verified
- Nov 2022
- First submitted
- 8 Jan 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18.
PubMed 36512649Metser U, Kulanthaivelu R, Chawla T, Johnson S, Avery L, Hussey D, Veit-Haibach P, Bernardini M, Hogen L. 18F-DCFPyL PET/CT in advanced high-grade epithelial ovarian cancer: A prospective pilot study. Front Oncol. 2022 Oct 13;12:1025475. doi: 10.3389/fonc.2022.1025475. eCollection 2022.
PubMed 36313720
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-DCFPyL PET/CT in High-grade Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03811899
- Acronym / sponsor ID
- 18-6241
- Conditions
- Stage III Ovarian Cancer, Stage IV Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Background:
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.
Study Design:
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.
Detailed description
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.
Primary Objective
To determine whether HG EOCs are 18F-DCFPyL avid on PET/CT.
Secondary Objectives:
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm study to determine whether HG EOC are 18F-DCFPyL-avid.
| Arm | Type | Receives |
|---|---|---|
| 18F-DCFPyL PET/CT imaging | Experimental | Diagnostic Test: 18F-DCFPyLWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Cytological or histological diagnosis of high grade epithelial ovarian cancer, or clinical suspicious of HG EOC based on symptoms, physical exam, tumor markers and imaging findings.
- Clinical stage III or IV, being considered for primary debulking surgery or NACT.
- Contrast-enhanced CT abdomen and pelvis within 6 weeks of PET (prior to enrollment).
Key exclusion criteria (3 listed)
- Inability to provide informed consent.
- Contraindication for PET examination as per institutional safety guidelines, including but not limited to pregnancy, or inability to lie still for PET examination.
- Evidence of the following epithelial ovarian cancer histological subtypes: Mucinous, low grade serous, low grade endometrioid and low-malignant potential tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-DCFPyLThe 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. | Diagnostic test | 18F-DCFPyL PET/CT imaging |
Primary outcome
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.
1 secondary outcome
18F-DCFPyL PET/CT vs. Contrast-enhanced CT
Time frame: Through study completion up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 36512649Kunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18.
- Derived from this study: PubMed 36313720Metser U, Kulanthaivelu R, Chawla T, Johnson S, Avery L, Hussey D, Veit-Haibach P, Bernardini M, Hogen L. 18F-DCFPyL PET/CT in advanced high-grade epithelial ovarian cancer: A prospective pilot study. Front Oncol. 2022 Oct 13;12:1025475. doi: 10.3389/fonc.2022.1025475. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ur Metser, MD principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-DCFPyL in people with Stage III Ovarian Cancer and Stage IV Ovarian Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 2 Nov 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-DCFPyL-avid PET/CT (time frame: Through study completion up to 2 years). 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 NCT03811899, which also lists 2 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 2 Nov 2022.