Clinical trial · Observational
O-RADS MRI System on Early Detection of Ovarian Cancer
A Prospective, Multicenter Study of O-RADS MRI System on Early Detection of Ovarian Cancer
- 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)
This study is designed to prospectively enroll individuals with suspected or potential risk of ovarian cancer across multiple centers. The investigation will implement rational optimization of the recommended imaging sequences and interpretation protocols within the standard Ovarian-Adnexal Reporting and Data System (O-RADS) MRI framework. By integrating comprehensive clinical parameters and histopathological correlations, we aim to validate the diagnostic efficacy and reproducibility of the optimized protocol against the standard O-RADS MRI system. The ultimate objective is to establish a refined methodology for accurately diagnosing early-stage or low-burden ovarian malignancies, thereby improving prognostic outcomes of patients with ovarian cancer.
Conditions
Conditions (2)
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 Metastatic | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
| Ovarian Cancer (OvCa) | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI contrast-enhancing agents | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- the diagnostic performance of the O-RADS MRI system in the early detection of ovarian cancer
- timeFrame
- 2 years
- description
- To evaluate the diagnostic performance of the O-RADS MRI system in the early detection of ovarian cancer (FIGO stages I-IIIC, epithelial ovarian carcinoma \[EOC\], tumor burden score ≤2), including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the receiver operating characteristic curve (AUC).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients meeting either of the following criteria based on initial diagnostic pelvic ultrasound findings (pelvic mass or pelvic effusion) suspicious for ovarian malignancy or at elevated risk for ovarian cancer:
1. Postmenopausal women or females ≥45 years with pelvic mass or effusion on ultrasound;
2. Postmenopausal women or females ≥45 years with serum CA125 ≥35 U/mL;
3. Females ≥35 years with a confirmed family history of ovarian or breast carcinoma;
4. Females ≥35 years harboring pathogenic/likely pathogenic BRCA1/2 germline mutations;
5. Females ≥35 years with BRCA1/2 mutations, non-suspicious adnexal lesions on ultrasound but planning prophylactic adnexectomy with availability of serial pathological sectioning.
② Ability to comply with the study protocol and adhere to scheduled follow-up assessments.
③ Provision of written informed consent.
Exclusion Criteria:
* ① Pregnant individuals
* Patients with histopathologically confirmed ovarian cancer
* Ovarian malignancy diagnosed by PET-CT at this institution
④ Patients undergoing neoadjuvant chemotherapy for confirmed ovarian cancer
⑤ Claustrophobia precluding tolerance of MRI examination
⑥ Contraindications to MRI: cardiac pacemakers, ferromagnetic implants, or high-risk metallic foreign bodies
⑦ History of gadolinium-based contrast agent (GBCA) hypersensitivity or intolerance
⑧ Severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73 m²)References
Publications (0)
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