Clinical trial · Interventional
Evaluation of 68Ga-FAPI-46 and 18F-FDG PET/CT Imaging for Detecting Recurrent Tumor Lesions in Patients of Ovarian Cancer
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
NCT06232122CI-TRIAL-00073414recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG | Diagnostic Test | — | UNRESOLVED |
| 68Ga-FAPI-46 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAPI ,PET/CT
- description
- Inject 68Ga-FAPI and then perform PET/CT scan.
- interventionNames
- Diagnostic Test: 68Ga-FAPI-46
- Diagnostic Test: 18F-FDG
Primary outcomes (1)
- measure
- 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
- timeFrame
- 2 months for individual participants to complete all visits
- description
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.