Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-FAPI-46, 18F-FDG.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: 30 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of 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
Overview
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
Detailed description
Ovarian cancer is the eighth most common cancer worldwide in females and usually diagnosed at an advanced stage. Serum cancer antigen 125 (CA125) is widely used in ovarian cancer. An elevation in CA125 levels can precede a clinically apparent recurrence by 3 to 6 months and 18F-FDG PET/CT can modify management in approximately half of these patients. However. 18F-FDG PET/CT may yield false negative results. 68Ga-FAPI-46 PET/CT shows potential here. This study is to assess the diagnostic performances of 68Ga-FAPI-46 and 18F-FDG PET/CT for ovarian cancer recurrence in patients with CA125 elevation from complete response after therapy.
Interventions
- Diagnostic test 68Ga-FAPI-46
Intravenous injection of one dosage of 2 mCi 68Ga-FAPI-46 - Diagnostic test 18F-FDG
Intravenous injection of one dosage of 5-10mCi 18F-FDG
Primary outcome measures
- 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 [Time frame: 2 months for individual participants to complete all visits]
Secondary outcome measures (2)
- Progression-free survival (PFS) [Time frame: 5 years]
- Overall Survival (OS) [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Taiwan · 1 center
- Chang-Gung Memorial Hospital, Linkou Branch — Taoyuan City
Identifiers
NCT: NCT06232122 · 202102208A0