Using a new imaging technique to diagnose ovarian cancer
[68Ga]Ga-FAPI-46 PET/CT: the Diagnostic Accuracy for Primary Staging and Re-staging of Patients with Ovarian Cancer
This study is testing a new imaging technique called FAPI PET/CT to see if it can better diagnose ovarian cancer and help doctors make better treatment decisions for patients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Aalborg University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aalborg, North Denmark) |
| Trial ID | NCT05903807 on ClinicalTrials.gov |
What this trial studies
This study involves 50 patients with newly diagnosed ovarian cancer who will receive FAPI PET/CT scans alongside standard diagnostic procedures, including FDG PET/CT. The aim is to compare the effectiveness of FAPI PET/CT against conventional imaging methods, using histopathology as the reference standard to determine diagnostic accuracy. Additionally, the study will assess how FAPI PET/CT influences patient management and its prognostic value. The research seeks to explore the potential of FAPI PET/CT in detecting peritoneal metastases more effectively than traditional imaging.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed or highly suspected ovarian cancer who are deemed operable.
Not a fit: Patients with non-resectable or recurrent ovarian cancer, or those with other concurrent malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of ovarian cancer diagnosis and management.
How similar studies have performed: Previous cohort studies have shown promising results for FAPI PET/CT in ovarian cancer, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed with biopsy verified ovarian cancer or highly suspected to have ovarian cancer (based on all data presented at the gynecological cancer MDT) and referred to primary staging with FDG PET/CT * Deemed resectable and operable at the MDT with or without neoadjuvant chemotherapy * Considered physically and mentally able to participate in the research project * 18-years or older and able to consent to project participation * Can read and understand Danish Exclusion Criteria: * Patients with non-resectable, inoperable, or recurrent ovarian cancer * Patients with an imminent need for surgery or in an emergency * Known concurrent other malignancy within the previous 5 years other than non-melanoma skin cancer * Patients not suited for surgery or neoadjuvant chemotherapy followed by surgery * Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry * History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-46. * Severe claustrophobia unresponsive to oral anxiolytics * Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study. * Pregnant, lactating, or breastfeeding women. * Potential pregnant women of childbearing potential \[1\] not using effective contraceptives \[2\]. Potential pregnancy will be ascertained by a pregnancy test (urine humane choriogonadotropin (HCG)) or serum b-HCG within 48 hours prior to the FAPI PET/CT. * Inability to remain still for the duration of the examination 1. Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, i.e., not sterilized (bilateral tubectomy/occlusion, hysterectomy, bilateral oophorectomy) and not post-menopausal. In cases of uncertain menopausal status, serum follicle stimulating hormone (FSH) levels and menstruation history can be assessed 2. Effective contraceptives include sexual abstinence, vasectomized partner, combined hormonal contraception (oral, intravaginal, transdermal), progesterone-only contraceptive (oral, injectable, implantable), or working intrauterine device (hormonal, non-hormonal).
Where this trial is running
Aalborg, North Denmark
- Aalborg University Hospital — Aalborg, North Denmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Morten Bentestuen, MD
- Email: m.bentestuen@rn.dk
- Phone: +4597665500
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.