Evaluating the role of advanced imaging in gynecological cancers
Prognostic and Diagnostic Added Value of Medical Imaging in Staging and Treatment Planning of Gynecological Cancer (PRODIGYN)
This study is testing if advanced imaging techniques can help doctors better diagnose and treat women with cervical, endometrial, and ovarian cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Region Västerbotten Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Umeå) |
| Trial ID | NCT05855941 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the added diagnostic and prognostic value of advanced medical imaging techniques, such as FDG-PET/CT and FDG-PET/MRI, in patients with cervical, endometrial, and epithelial ovarian cancers. Participants will undergo four additional imaging procedures beyond standard clinical examinations and will be followed for five years to evaluate survival predictions and improve radiotherapy planning. The study includes both retrospective validation of imaging against clinical staging and prospective identification of prognostic biomarkers. Additionally, it seeks to enhance non-invasive lymph node staging and develop a machine learning tool for ovarian lesion characterization.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with newly diagnosed, untreated primary cervical, endometrial, or strongly suspected epithelial ovarian cancer.
Not a fit: Patients with imaging findings suggestive of other primary malignancies or those who are MRI incompatible will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival predictions and more effective treatment planning for patients with gynecological cancers.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for cancer diagnosis and treatment planning, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Previously untreated primary cervical, endometrial, or strongly suspected epithelial ovarian cancer. * Known clinical FIGO stage. * \>18 years old. * No other known current or previous malignancy within the last 10 years. Exclusion Criteria: * Imaging findings suggestive of other primary malignancy. * Previously included suspected epithelial ovarian cancer, later confirmed to be other diagnosis than epithelial ovarian cancer or "cancer abdominis". * MRI incompatible devices or patient unable to undergo MRI.
Where this trial is running
Umeå
- Centre for Gynecology and Obstetrics, Umea University Hospital — Umeå, Sweden (Recruiting)
Study contacts
- Principal investigator: Sara Strandberg, MD, PhD — Department of Radiation Sciences, Umea University/Radiology, Umea University Hospital
- Study coordinator: Erika Figaro
- Email: erika.figaro@regionvasterbotten.se
- Phone: +46907850499
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.