Clinical trial · Observational
Prognostic and Diagnostic Added Value of Medical Imaging in Gynecological Cancer (PRODIGYN)
Prognostic and Diagnostic Added Value of Medical Imaging in Staging and Treatment Planning of Gynecological Cancer (PRODIGYN)
- 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)
The goal of this observational study is to learn about the added diagnostic and prognostic value of advanced medical imaging procedures in cervical cancer, endometrial cancer and ovarian cancer. The main questions it aims to answer are: * Does advanced medical imaging predict survival? * Can advanced medical imaging improve radiotherapy target planning? * Are advanced medical imaging results associated with risk markers found in tumor tissue? Participants will * Undergo four additional imaging procedures, as compared to clinical routine examinations, two at baseline and two after three months. * Be subject to clinical follow-up for five years.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Cancer | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG-PET/CT and FDG-PET/MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cervix cancer
- description
- Newly diagnosed cervix cancer.
- interventionNames
- Diagnostic Test: FDG-PET/CT and FDG-PET/MRI
- label
- Endometrial cancer
- description
- Newly diagnosed endometrial cancer.
- interventionNames
- Diagnostic Test: FDG-PET/CT and FDG-PET/MRI
- label
- Ovarian cancer
- description
- Strong suspicion of newly diagnosed epithelial ovarian cancer; histopathological confirmation required within 6 months after inclusion.
- interventionNames
- Diagnostic Test: FDG-PET/CT and FDG-PET/MRI
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAasa M, Lindquist D, Ottander U, Strandberg SN. Primary staging with 2[18F]-FDG-PET/CT and -PET/MRI and radiotherapy response evaluation with MRI in uterine cervical cancer: an interim analysis of a prospective clinical trial. EJNMMI Rep. 2025 Jan 10;9(1):3. doi: 10.1186/s41824-024-00236-2. PMID 39789229