68Ga-FAPINCT05856409
Clinical Application of 68Ga-FAPI PET Imaging in Detection of Ovarian Cancer Recurrence
An observational study of 68Ga-FAPI and Ovarian Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
This is a prospective study to investigate the potential efficacy of 68Ga-FAPI PET/CT for recurrence detection of epithelial ovarian cancer in comparison with 18F-FDG PET/CT. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- 68Ga-FAPI, Ovarian Cancer, Epithelial Ovarian Cancer
- What is being tested?
- 68Ga-FAPI
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2023to 31 Dec 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 18 to 80 years
- Women only
- Adult, Older adult
Study population: A prospective cohort of patients with clinically suspected recurrent ovarian cancer were enrolled, who underwent paired 68Ga-FAPI and 18F-FDG PET/CT.
Who may be able to join
- adult patients (age>18 and<80 years)
- patients with clinically suspected recurrent ovarian cancer
- patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for the most proper treatment strategy within 1 week
- patients who did not receive any other treatment 4 weeks before PET imaging
Who cannot join
- pregnant patients
- patients with poor performance status
- patients unwilling to provide written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Jianjun Liu, PH.D, +86 13301826638, nuclearj@163.com
About this study
This is a prospective study to investigate the potential efficacy of 68Ga-FAPI PET/CT for recurrence detection of epithelial ovarian cancer in comparison with 18F-FDG PET/CT.
Read the detailed description
Gallium 68-labeled fibroblast-activation protein inhibitor (68Ga-FAPI) has recently been a potential radiotracer for gynecological malignancies,including ovarian cancer. Early detection and localization of sites of recurrence helps to identify ovarian cancer patients who will benefit the most from secondary surgery, chemotherapy, or radiation therapy. Its clinical utility for recurrence detection of epithelial ovarian cancer and histological validation of FAPI findings is not well established.
- Being tested
- 68Ga-FAPI
- Keywords
- 68Ga-FAPI, PET, ovarian cancer, recurrence detection
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPIDiagnostic test
[68Ga]-FAPI is tumor imaging agent for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF)
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance
Sensitivity and Specificity of 68Ga-FAPI PET/CT for recurrence in comparison with 18F-FDG PET/CT
Measured: 1 year
Maximum standardized uptake value（SUVmax）
Measurement of the maximum standardized uptake value of the lesion
Measured: 1 year
Tumor-to-background ratio (TBR)
TBR was calculated according to the formula：TBR=SUVmax of lesion/SUVmax of background
Measured: 1 year
Secondary outcomes (1)
Correlation between FAPI expression and SUV in PET
Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining of pathological specimen
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 posted12 May 2023
- Study start10 May 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 68Ga-FAPIStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianjun Liu, PH.D, Principal investigator, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856409
- Sponsor's protocol ID
- LY2023-024-B
- Status last verified
- Aug 2023
- First submitted
- 17 Apr 2023
- Last updated
- 16 Aug 2023
- 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 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of 68Ga-FAPI PET Imaging in Detection of Ovarian Cancer Recurrence
- ClinicalTrials.gov ID
- NCT05856409
- Acronym / sponsor ID
- LY2023-024-B
- Keywords
- 68Ga-FAPI, PET, ovarian cancer, recurrence detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 May 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.
This is a prospective study to investigate the potential efficacy of 68Ga-FAPI PET/CT for recurrence detection of epithelial ovarian cancer in comparison with 18F-FDG PET/CT.
Detailed description
Gallium 68-labeled fibroblast-activation protein inhibitor (68Ga-FAPI) has recently been a potential radiotracer for gynecological malignancies,including ovarian cancer. Early detection and localization of sites of recurrence helps to identify ovarian cancer patients who will benefit the most from secondary surgery, chemotherapy, or radiation therapy. Its clinical utility for recurrence detection of epithelial ovarian cancer and histological validation of FAPI findings is not well established.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- A prospective cohort of patients with clinically suspected recurrent ovarian cancer were enrolled, who underwent paired 68Ga-FAPI and 18F-FDG PET/CT.
Key inclusion criteria (4 listed)
- adult patients (age>18 and<80 years)
- patients with clinically suspected recurrent ovarian cancer
- patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for the most proper treatment strategy within 1 week
- patients who did not receive any other treatment 4 weeks before PET imaging
Key exclusion criteria (3 listed)
- pregnant patients
- patients with poor performance status
- patients unwilling to provide written informed consent
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[68Ga]-FAPI is tumor imaging agent for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) | Diagnostic test | – |
Primary outcome
Diagnostic Performance
Time frame: 1 year
Sensitivity and Specificity of 68Ga-FAPI PET/CT for recurrence in comparison with 18F-FDG PET/CT
Maximum standardized uptake value（SUVmax）
Time frame: 1 year
Measurement of the maximum standardized uptake value of the lesion
Tumor-to-background ratio (TBR)
Time frame: 1 year
TBR was calculated according to the formula：TBR=SUVmax of lesion/SUVmax of background
1 secondary outcome
Correlation between FAPI expression and SUV in PET
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
Active, not recruiting
68Ga-FAPI PET/CT in the Staging of High-Grade Epithelial Ovarian Cancers: A Pilot Study
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RecruitingPhase 1
A Study of 68Ga-FAPI Breast PET/MRI Scans in People With Breast Cancer
Breast Cancer, Invasive Breast Cancer
RecruitingObservational study
FAPI in Rectal Cancer TNT
Rectal Neoplasms Malignant
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.
Jianjun Liu, PH.D principal investigator
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
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 68Ga-FAPI and Ovarian Cancer, run by RenJi 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 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: status not confirmed, as of the sponsor's last update on 16 Aug 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 Tingting Wang, PH.D (15000091930, wangtt_shca@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance (time frame: 1 year). The study lists 3 primary outcomes in all. 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 16 Aug 2023.