Clinical trial · Observational
Imaging Study in Advanced Ovarian Cancer
A Comparison Between Ultrasound, CT (CT) and Whole-body Diffusion-weighted MRI (WB-DWI/MRI) in the Assessment of Operability in Patients With Ovarian Cancer
NCT03808792CI-TRIAL-00036618ISAACunknownClinicalTrials.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)
The aim of the study is the assessment of tumour sites critical for the achievement of optimal cytoreduction in patients with advanced ovarian cancer using Ultrasound, CT and WB-DWI/MRI. The study uses an equivalence design with a hypothesis that cases with non-resectable disease identified by Index test (Ultrasound, CT and WB-DWI MRI) are equivalent to a portion of cases identified during surgery.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound, CT and WB-DWI/MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ovarian cancer patients
- description
- Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer submitted to the index test (Ultrasound, CT and WB/DWI-MRI) with perspective of primary surgery
- interventionNames
- Diagnostic Test: Ultrasound, CT and WB-DWI/MRI
Primary outcomes (1)
- measure
- Preoperative identification of patients with ovarian/tubal cancer in whom optimal debulking (R0/R1) can not be achieved by US and CT scan.
- timeFrame
- 24 months
- description
- Optimal debulking is defined as residual disease \<1cm
Secondary outcomes (11)
- measure
- Assessment of the diagnostic performance in the detection of involvement of individual sites relevant for clinical management and in the detection of 24 individual sites described in the evaluation form.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer using subjective assessment by experienced sonographer. 2. Surgery (PDS or IDS) within 4 weeks from the index test. 3. 18 \> Age \< 80. 4. ECOG (Eastern Cooperative Oncology Group) grade \< 3. 5. Patients after NACT can be included. Exclusion Criteria: 1. Lesions suspected as being borderline ovarian tumors (BOT) on ultrasound. 2. Patients with supradiaphragmatic metastases 3. Contraindications to CT 4. Medical contraindications to surgery 5. Refusal or withdrawal of written informed consent 6. Time lapse between ultrasound and surgery more than 4 weeks 7. Current pregnancy
References
Publications (2)
- DERIVEDFischerova D, Pinto P, Pesta M, Blasko M, Moruzzi MC, Testa AC, Franchi D, Chiappa V, Alcazar JL, Wiesnerova M, Cibula D, Valentin L; collaborators. Ultrasound examiners' ability to describe ovarian cancer spread using preacquired ultrasound videoclips from a selected patient sample with high prevalence of cancer spread. Ultrasound Obstet Gynecol. 2025 May;65(5):641-652. doi: 10.1002/uog.29208. Epub 2025 Apr 18. PMID 40247746
- DERIVEDPinto P, Valentin L, Borcinova M, Wiesnerova M, Filip F, Burgetova A, Masek M, Lambert L, Chiappa V, Franchi D, Testa AC, Moro F, Avesani G, Panico C, Alessi S, Pricolo P, Vigorito R, Calareso G, Kocian R, Slama J, Fagotti A, Urbinati AMV, Signorelli M, Bertolina F, Cibula D, Fischerova D. Patient satisfaction with ultrasound, whole-body CT and whole-body diffusion-weighted MRI for pre-operative ovarian cancer staging: a multicenter prospective cross-sectional survey. Int J Gynecol Cancer. 2024 Jun 3;34(6):871-878. doi: 10.1136/ijgc-2023-005264. PMID 38531539