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NCT Number: NCT07009743

O-RADS MRI System on Early Detection of Ovarian Cancer

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Postmenopausal women or females ≥45 years with pelvic mass or effusion on ultrasound;
  • Postmenopausal women or females ≥45 years with serum CA125 ≥35 U/mL;
  • Females ≥35 years with a confirmed family history of ovarian or breast carcinoma;
  • Females ≥35 years harboring pathogenic/likely pathogenic BRCA1/2 germline mutations;
  • 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)

Treatment and study plan

MRI contrast-enhancing agents

Diagnostic Test

All patients underwent standard pelvic MRI examinations (1.5T or 3T) with the following sequences: T2-weighted imaging (T2WI), T1-weighted imaging (T1WI) with and without fat suppression; axial, sagittal, and coronal post-contrast T1WI following intravenous administration of gadolinium-based contrast agents (GBCA); functional sequences including dynamic contrast-enhanced MRI (DCE-MRI) and diffusion-weighted imaging MRI (DWI-MRI). Enhancement sequences may be omitted if no adnexal masses were identified on T2WI, T1WI, or DWI sequences.

Primary outcomes

  1. the diagnostic performance of the O-RADS MRI system in the early detection of ovarian cancer

    Time frame: 2 years

    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).

Sponsors and collaborators

Lead sponsor

Shanghai Gynecologic Oncology Group

Other Gov

Registry information

Official study title

A Prospective, Multicenter Study of O-RADS MRI System on Early Detection of Ovarian Cancer

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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