Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer
1 other identifier
interventional
45
1 country
1
Brief Summary
A prospective cohort imaging study in a single institution to evaluate 68Ga- FAPI-46 and 18F-FDG PET/CT imaging for detecting recurrent tumor lesions in patients of ovarian cancer with CA125 elevation from complete response after therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable ovarian-cancer
Started Aug 2022
Longer than P75 for not_applicable ovarian-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 20, 2024
CompletedFirst Posted
Study publicly available on registry
January 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
January 30, 2024
January 1, 2024
6 years
January 20, 2024
January 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic performances of 68Ga-FAPI and 18F-FDG PET/CT for ovarian cancer recurrence after one year from PET/CT imaging in Per-Protocol Analysis Dataset
Diagnostic performance is defined as the AUC value of ROC curve (sensitivity against 1-specificity at different PET/CT imaging scores ranged from 1 to 4). Cancer recurrence is defined by pathological or imaging evidence up to one year after 68Ga-FAPI-46 PET/CT study.
2 months for individual participants to complete all visits
Secondary Outcomes (2)
Progression-free survival (PFS)
5 years
Overall Survival (OS)
5 years
Study Arms (1)
68Ga-FAPI ,PET/CT
EXPERIMENTALInject 68Ga-FAPI and then perform PET/CT scan.
Interventions
Intravenous injection of one dosage of 2 mCi 68Ga-FAPI-46
Intravenous injection of one dosage of 5-10mCi 18F-FDG
Eligibility Criteria
You may qualify if:
- Pathologically proven ovarian cancer with complete response after therapy
- Age between 30 and 80
- Elevation of serum CA125 value above the normal range (\>35 U/mL) or doubling of serum CA125 value within the normal range
- ECOG performance status grade 0 or 1 and willing to receive further therapy if disease recurrence is confirmed
- Willing to enter this prospective study with signed informed consent form
You may not qualify if:
- Patients with history of other malignancy
- Patients who are pregnant or lactating
- Patients with fasting fingerstick glucose level higher than 200 mg/dl
- Known allergic reactions to components of the radiopharmaceutical solutions for intravenous injection for 68Ga-FAPI-46 or 18F-FDG imaging studies
- Patients who are incapable of lying still for 30 minutes to receive the PET/CT scan as assessed by investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang-Gung Memorial Hospital, Linkou Branch
Taoyuan, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 20, 2024
First Posted
January 30, 2024
Study Start
August 1, 2022
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
January 30, 2024
Record last verified: 2024-01