Ovarian CancerNCT05824247
A Prospective Cohort Study of 68ga-FAPI-pet-ct Versus FDG-pet-ct for Ovarian Cancer
An observational study of Ovarian Cancer, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
A study to discuss the advantage of Fapi PET- CT in the initial diagnosis staging and lesion determination of ovarian cancer,whether it can be a evaluation strategy as an R0 evaluation tool or a prediction tool of chemotherapy response and evaluation of prognosis. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- 68Ga-FAPI-PET-CT
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Jun 2025
- Phase
- Observational
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary epithelial ovarian cancer confirmed by clinical consideration or puncture
Who may be able to join
- Patients with primary epithelial ovarian cancer confirmed by clinical consideration or puncture
- PET-CT was chose as the initial imaging evaluation tool.
Who cannot join
- Patients with acute inflammation
- Lacking of clinical data
- Severe complications and PET-CT contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Zhengyi Chen, doctor, 18810535290, 407136123@qq.com
About this study
A study to discuss the advantage of Fapi PET- CT in the initial diagnosis staging and lesion determination of ovarian cancer,whether it can be a evaluation strategy as an R0 evaluation tool or a prediction tool of chemotherapy response and evaluation of prognosis.
Read the detailed description
Ovarian cancer is a challenging disease. It is difficult to diagnose early, and the recurrence rate is high after initial treatment. In the past decades, in addition to cancer treatment methods, imaging evaluation has also made corresponding progress. In particular, molecular imaging using FDG-PET / CT has shown a strong role in ovarian cancer. It can locate metabolic changes before anatomical changes, point out small lymph node (LN) metastasis, find distant metastasis and definite recurrence.In terms of diagnosis, several studies have shown that PET-CT is superior to CT in ovarian cancer staging and has obvious advantages in the determination of extraperitoneal metastasis; In terms of predicting whether ro surgery can be performed, there are some mature scoring systems, such as eisenkop,suidan score etc.but there is still no unique scoring mode suitable for PET-CT; Despite the above advantages, the nonspecific uptake mechanism of FDG-PET may lead to false positive results.Cancer associated fibroblasts (CAFs) are one of the factors that independently mediate tumor growth and metastasis. They are also related to extracellular fibrous tissue and tumor size Fibroblast activation protein (FAP) is overexpressed in fibroblasts of many epithelial cancers, but rarely expressed in normal tissues.Therefore, imaging with FAP as a marker is a promising way in many tumor types In our previous study, [68Ga] GA dotafapi - PET / CT D compared with [18F] - FDG PET / CT has advantages in detecting primary and metastatic lesions of many tumors, especially peritoneal metastatic tumors, such as ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- 68Ga-FAPI-PET-CT
- Keywords
- Ovarian cancer, FAPI, PET-CT
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-PET-CTDevice
a new technology that using Fibroblast activation protein （FAP）inhibitor as the tracer of PET-CT
What is being measured
The primary outcome is the main question the study is designed to answer.
coincidence rate
The consistency between the lesions detected by PET CT and those detected during operation (based on pathology)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Apr 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824247
- Sponsor's protocol ID
- XMYY-2019-XJS1130
- Status last verified
- Apr 2022
- First submitted
- 3 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of 68ga-FAPI-pet-ct Versus FDG-pet-ct for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05824247
- Acronym / sponsor ID
- XMYY-2019-XJS1130
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, FAPI, PET-CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 21 Apr 2023 (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.
A study to discuss the advantage of Fapi PET- CT in the initial diagnosis staging and lesion determination of ovarian cancer,whether it can be a evaluation strategy as an R0 evaluation tool or a prediction tool of chemotherapy response and evaluation of prognosis.
Detailed description
Ovarian cancer is a challenging disease. It is difficult to diagnose early, and the recurrence rate is high after initial treatment. In the past decades, in addition to cancer treatment methods, imaging evaluation has also made corresponding progress. In particular, molecular imaging using FDG-PET / CT has shown a strong role in ovarian cancer. It can locate metabolic changes before anatomical changes, point out small lymph node (LN) metastasis, find distant metastasis and definite recurrence.In terms of diagnosis, several studies have shown that PET-CT is superior to CT in ovarian cancer staging and has obvious advantages in the determination of extraperitoneal metastasis; In terms of predicting whether ro surgery can be performed, there are some mature scoring systems, such as eisenkop,suidan score etc.but there is still no unique scoring mode suitable for PET-CT; Despite the above advantages, the nonspecific uptake mechanism of FDG-PET may lead to false positive results.Cancer associated fibroblasts (CAFs) are one of the factors that independently mediate tumor growth and metastasis. They are also related to extracellular fibrous tissue and tumor size Fibroblast activation protein (FAP) is overexpressed in fibroblasts of many epithelial cancers, but rarely expressed in normal tissues.Therefore, imaging with FAP as a marker is a promising way in many tumor types In our previous study, [68Ga] GA dotafapi - PET / CT D compared with [18F] - FDG PET / CT has advantages in detecting primary and metastatic lesions of many tumors, especially peritoneal metastatic tumors, such as ovarian cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary epithelial ovarian cancer confirmed by clinical consideration or puncture
Key inclusion criteria (2 listed)
- Patients with primary epithelial ovarian cancer confirmed by clinical consideration or puncture
- PET-CT was chose as the initial imaging evaluation tool.
Key exclusion criteria (3 listed)
- Patients with acute inflammation
- Lacking of clinical data
- Severe complications and PET-CT contraindications
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-PET-CTa new technology that using Fibroblast activation protein （FAP）inhibitor as the tracer of PET-CT | Device | – |
Primary outcome
coincidence rate
Time frame: 1 year
The consistency between the lesions detected by PET CT and those detected during operation (based on pathology)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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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?
An observational study of Ovarian Cancer, run by The First Affiliated Hospital of Xiamen University 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 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. 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.
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 JianFa Lan, Doctor (18810535017, 407136123@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coincidence rate (time frame: 1 year). 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 21 Apr 2023.