Evaluating imaging techniques for detecting recurrent 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
NA · Chang Gung Memorial Hospital · NCT06232122
This study is testing two different imaging methods to see which one is better at finding recurring ovarian cancer in patients whose CA125 levels have gone up after treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | Female |
| Sponsor | Chang Gung Memorial Hospital (other) |
| Locations | 1 site (Taoyuan City) |
| Trial ID | NCT06232122 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of two imaging techniques, 68Ga-FAPI-46 and 18F-FDG PET/CT, in detecting recurrent tumor lesions in patients with ovarian cancer who have shown an elevation in CA125 levels after achieving a complete response to therapy. The research will involve a prospective cohort of patients at a single institution, focusing on those whose CA125 levels indicate potential recurrence. By comparing the diagnostic performances of both imaging methods, the study seeks to improve management strategies for ovarian cancer patients.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 30 to 80 with pathologically proven ovarian cancer who have achieved a complete response after therapy and have elevated CA125 levels.
Not a fit: Patients with a history of other malignancies, those who are pregnant or lactating, or individuals unable to undergo the required imaging procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of recurrent ovarian cancer, allowing for timely intervention and improved patient outcomes.
How similar studies have performed: Previous studies have shown that 18F-FDG PET/CT can modify management in a significant number of patients, indicating that this approach has potential, though the use of 68Ga-FAPI-46 is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taoyuan City
- Chang-Gung Memorial Hospital, Linkou Branch — Taoyuan City, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Feng-Yuan Liu
- Email: billliu@cgmh.org.tw
- Phone: 0975365782
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, 68Ga-FAPI-46, 18F-FDG, CA-125