Epithelial Ovarian CancerPhase 2NCT04504110
68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings
A Phase 2 study testing 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT in people with Epithelial Ovarian Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Epithelial ovarian cancer (EOC) is a tumor entity featured by frequent involvement of peritoneum, also called peritoneal carcinomatosis. It is a type of metastasis accompanied by significant cancer-associated fibroblasts (CAFs) accumulation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2020to Aug 2021
- Phase
- Phase 2
- 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
- Written informed consent signed
- EOC patients who are scheduled for surgery. The diagnosis of EOC should be based on the previous histological results or cytological evaluation combined with a serum CA-125 to carcinoembryonic antigen ratio>25 to confirm the primary diagnosis and exclude a nongynecologic cancer.
Who cannot join
- Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI-04.
- Tumor-specific treatment is necessary between the scans and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy.
- Pregnant or breast-feeding women.
- Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yupei Zhao, MD
About this study
Official title: A Prospective Study to Evaluate 68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings
Epithelial ovarian cancer (EOC) is a tumor entity featured by frequent involvement of peritoneum, also called peritoneal carcinomatosis. It is a type of metastasis accompanied by significant cancer-associated fibroblasts (CAFs) accumulation. Fibroblast activation protein (FAP) is a protein that is overexpressed on CAFs and can be non-invasively monitored by a novel radiotracer called 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT). In this study, we will explore the value of 68Ga-FAPI-04 PET/CT in patients with epithelial ovarian cancer who are scheduled for surgical intervention. The findings of 68Ga-FAPI-04 PET/CT will also be compared with that of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) PET/CT, which is one of the most commonly used modalities in evaluating EOC, and histological findings.
Read the detailed description
Patients with epithelial ovarian cancer who are scheduled for surgical intervention will be recruited in this study. They will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT study before the surgery. No tumor-specific treatment is allowed between the scan and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy. Three types of lesions will be marked based on 68Ga-FAPI-04 and 18F-FDG PET/CT findings, which is FAPI+/FDG-, FAPI-/FAPI+, and FAPI+/FDG+ lesions. The marked lesions will be explored by the surgeon, resected if possible, and compared with histological results. A fourth type of lesion will be added into the analysis if that lesion is both FAPI and FAP negative but is a histological-confirmed positive lesion.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CTDiagnostic test
Patients with epithelial ovarian cancer who are scheduled for surgical intervention will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT study before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Epithelial ovarian cancer | Experimental | 68Ga-FAPI-04 and 18F-FDG PET/CT Receives: Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax of positive lesions
68Ga-FAPI-04 and 18F-FDG accumulation will be determined using SUVmax
Measured: 1 hour after tracer injection
Secondary outcomes (1)
Histological findings
The presence of tumor cells on resected specimen will be evaluated by pathologists. The FAP expression will be determined using immunohistochemical staining using anti-FAP antibody (Abcam).
Measured: 60 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start5 Aug 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504110
- Sponsor's protocol ID
- FAPIEOC
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate 68Ga-FAPI-04 and 18F-FDG PET/CT in Patients With Epithelial Ovarian Cancer: Compared With Histological Findings
- ClinicalTrials.gov ID
- NCT04504110
- Acronym / sponsor ID
- FAPIEOC
- Conditions
- Epithelial Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 7 Aug 2020 (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.
Epithelial ovarian cancer (EOC) is a tumor entity featured by frequent involvement of peritoneum, also called peritoneal carcinomatosis. It is a type of metastasis accompanied by significant cancer-associated fibroblasts (CAFs) accumulation. Fibroblast activation protein (FAP) is a protein that is overexpressed on CAFs and can be non-invasively monitored by a novel radiotracer called 68Ga-FAPI-04 positron emission tomography/computed tomography (PET/CT). In this study, we will explore the value of 68Ga-FAPI-04 PET/CT in patients with epithelial ovarian cancer who are scheduled for surgical intervention. The findings of 68Ga-FAPI-04 PET/CT will also be compared with that of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (18F-FDG) PET/CT, which is one of the most commonly used modalities in evaluating EOC, and histological findings.
Detailed description
Patients with epithelial ovarian cancer who are scheduled for surgical intervention will be recruited in this study. They will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT study before the surgery. No tumor-specific treatment is allowed between the scan and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy. Three types of lesions will be marked based on 68Ga-FAPI-04 and 18F-FDG PET/CT findings, which is FAPI+/FDG-, FAPI-/FAPI+, and FAPI+/FDG+ lesions. The marked lesions will be explored by the surgeon, resected if possible, and compared with histological results. A fourth type of lesion will be added into the analysis if that lesion is both FAPI and FAP negative but is a histological-confirmed positive lesion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epithelial ovarian cancer | Experimental | Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT68Ga-FAPI-04 and 18F-FDG PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent signed
- EOC patients who are scheduled for surgery. The diagnosis of EOC should be based on the previous histological results or cytological evaluation combined with a serum CA-125 to carcinoembryonic antigen ratio>25 to confirm the primary diagnosis and exclude a nongynecologic cancer.
Key exclusion criteria (4 listed)
- Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI-04.
- Tumor-specific treatment is necessary between the scans and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy.
- Pregnant or breast-feeding women.
- Any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
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 |
|---|---|---|
| 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CTPatients with epithelial ovarian cancer who are scheduled for surgical intervention will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT study before the surgery. | Diagnostic test | Epithelial ovarian cancer |
Primary outcome
SUVmax of positive lesions
Time frame: 1 hour after tracer injection
68Ga-FAPI-04 and 18F-FDG accumulation will be determined using SUVmax
1 secondary outcome
Histological findings
Time frame: 60 day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT in people with Epithelial Ovarian Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 10 Aug 2020. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjia Zhu, MD (+86 18614080164, zhuwenjia_pumc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax of positive lesions (time frame: 1 hour after tracer injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2020.