Clinical trial NCT07009743: O-RADS MRI System on Early Detection of Ovarian Cancer
Official title: A Prospective, Multicenter Study of O-RADS MRI System on Early Detection of Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Cancer (OvCa)
Ovarian Cancer Metastatic
Lead sponsor: Shanghai Gynecologic Oncology Group
Sponsor class: OTHER_GOV
First posted: 2025-06-08
Enrollment: 2549
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with epithelial ovarian carcinoma (EOC) at FIGO stages I-IIB and stage IIIC (with a tumor burden score \<2).

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: the diagnostic performance of the O-RADS MRI system in the early detection of ovarian cancer
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
References: