NCT07009743Active, not recruiting
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 · Last updated 8 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2549 (estimated)
- First submitted
- 21 May 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Diseases
- Ovarian cancer
- NCT number
- NCT07009743
What you commit to
- Study type: Observational
- Planned participants: 2549
- From 1 Jan 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Who the study is looking for
- 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.
Age in the registry: 35 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.