Ovarian Cancer (OvCa)NCT07009743
O-RADS MRI System on Early Detection of Ovarian Cancer
An observational study of Ovarian Cancer (OvCa) and Ovarian Cancer Metastatic, run by Shanghai Gynecologic Oncology Group at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Ovarian Cancer (OvCa), Ovarian Cancer Metastatic
- What is being tested?
- MRI contrast-enhancing agents
- Type of treatment
- Injection or infusion
- How many people
- 2,549 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with epithelial ovarian carcinoma (EOC) at FIGO stages I-IIB and stage IIIC (with a tumor burden score <2).
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter Study of 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.
- Conditions
- Ovarian Cancer (OvCa), Ovarian Cancer Metastatic
- Being tested
- MRI contrast-enhancing agents
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI contrast-enhancing agentsDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic performance of the O-RADS MRI system in the early detection of ovarian cancer
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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cancer (OvCa)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,549 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009743
- Sponsor's protocol ID
- O-RADS MRI
- Status last verified
- Jun 2025
- First submitted
- 21 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study of O-RADS MRI System on Early Detection of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07009743
- Acronym / sponsor ID
- O-RADS MRI
- Conditions
- Ovarian Cancer (OvCa), Ovarian Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,549 participants (estimated)
- Lead sponsor
- Shanghai Gynecologic Oncology GroupOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with epithelial ovarian carcinoma (EOC) at FIGO stages I-IIB and stage IIIC (with a tumor burden score <2).
Key inclusion criteria (8 listed)
- 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:
- ② Ability to comply with the study protocol and adhere to scheduled follow-up assessments.
- ③ Provision of written informed consent.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI contrast-enhancing agentsAll 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. | Diagnostic test | – |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer (OvCa) and Ovarian Cancer Metastatic, run by Shanghai Gynecologic Oncology Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnostic performance of the O-RADS MRI system in the early detection of ovarian cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.