Ovarian NeoplasmsNCT07202429
Additive Role of ADC Value to ORADS in Adnexal Lesions
An observational study of Ovarian Neoplasms, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of the impact of adding mean apparent diffusion coefficient (ADC mean) measurements to the Ovarian-Adnexal Imaging Reporting and Data System MRI (O-RADS MRI) scoring for adnexal lesion characterization using a combined O-RADS MRI/ADC mean reading approach. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: female patients any age with ovarian lesions
Who may be able to join
- (1) Female patient any age with at least one adnexal lesion detected by U/S reported as O-RADS3to5.
- The interval between operation and ultrasonography did not exceed 120 days. (3) Subsequent surgery with histological examination or stability at follow-up imaging for at least 1 year.
- For bilateral adnexal masses, the mass with the most complex features was included.
- (5)If two masses had similar morphologies, the largest mass was included.
Who cannot join
- Female patient any age with adnexal lesions detected by U/S reported as O-RADS1and2.
- Cysts that were deemed to be clearly physiological and less than 3 cm in maximum diameter.
- No histopathological findings or follow-up < one year .
- Previous bilateral adnexectomy.
- Contraindications to MRI examination including
- Absolute contraindications: such as The cardiac implantable electronic device (CIED), Metallic intraocular foreign bodies, ….)
- Relative contraindications: such as Coronary and peripheral artery stents, Ocular prosthesis,……)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr Al-Ainy Faculty of Medicine, Cairo University
Cairo, Cairo Governorate, 11562
About this study
Official title: Additive Role of Mean Apparent Diffusion Coefficient (ADCmean) Value Measurements to the Ovarian-Adnexal Reporting and Data System (O-RADS) MRI Score in Stratifications of Adnexal Lesions
Evaluation of the impact of adding mean apparent diffusion coefficient (ADC mean) measurements to the Ovarian-Adnexal Imaging Reporting and Data System MRI (O-RADS MRI) scoring for adnexal lesion characterization using a combined O-RADS MRI/ADC mean reading approach.
Read the detailed description
The patients will be referred from the Gynecology department to the Kasr Al-Ainy Radiology department (Women's imaging unit) based on preliminary ultrasound examination used for cases selection.
Female patients with adnexal lesions on ultrasound were subjected to MRI examination, Standardised MRI sequences will used, including DWI and DCE sequences. blinded to histopathological data, according to the O-RADS MRI scoring system. A quantitative analysis method will applied by placing a ROI on the ADC maps obtained from single-exponential DWI sequences.
Additive role of ADC value will be comparied to O-RADs according to gold standard (pathological examination of adnexal lesions) after excision to correlate results of imaging and pathology.
MRI examination: MR imaging was performed using a 1.5-T magnet using torso coil Diffusion WI: with b values 0, 500, 1000 and 1500 as well as ADC map. Dynamic contrast enhanced study: using 10cc of Gadopentetate dimeglumine and 20ml of saline. Injection is manual. Examination time is 4minutes with 8 series. Scan time for each series: 32secs
- Conditions
- Ovarian Neoplasms
- Being tested
- MRI
- Keywords
- MRI-ORADS, ADC value, Ovarian neoplasms
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
"Multiparametric MRI of adnexal lesions, including conventional sequences, diffusion-weighted imaging (DWI) with apparent diffusion coefficient (ADC) measurement, and dynamic contrast-enhanced (DCE) MRI. Imaging findings were evaluated using the O-RADS MRI scoring system."
| Study group | Role | What they receive |
|---|---|---|
| Benign Adnexal Lesions | Description: Participants with adnexal lesions that were confirmed as benign on histopathology.
Description: Dynamic MRI imaging including diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) measurement, used for lesion characterization with O-RADS scoring. Receives: Device: MRI | |
| Borderline adnexal lesions | Description: Participants with adnexal lesions that were confirmed as borderline on histopathology.
Description: Dynamic MRI imaging including diffusion-weighted imaging (DWI) and ADC measurement, used for lesion characterization with O-RADS scoring. Receives: Device: MRI | |
| Malignant adnexal lesions | Description: Participants with adnexal lesions that were confirmed as maligannt on histopathology.
Description: Dynamic MRI imaging including diffusion-weighted imaging (DWI) and ADC measurement, used for lesion characterization with O-RADS scoring. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean ADC value of adnexal lesions
Measurement of mean apparent diffusion coefficient (ADCmean) values in adnexal lesions using diffusion-weighted imaging (DWI). Unit of Measure: ADC value (×10-³ mm²/s)
Measured: March 2023 to june 2024
Diagnostic performance of O-RADS MRI + ADC system
Evaluation of diagnostic performance (sensitivity, specificity, accuracy) of O-RADS MRI scoring combined with ADC values, compared with O-RADS MRI system alone. Unit of Measure: Percentage (%)
Measured: March 2023 to june 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Mar 2023
- Primary completion1 Jun 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Badawy, Cairo University
- Investigators
- Lamia Salah Eldin, M.D, Principal investigator, kasr-alainy cairo universityManar Alaa Eldin Osman, M.D, Study director, kasr-alainy cairo universityMohammed Aly Shalaby, M.D, Study chair, kasr-alainy cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202429
- Sponsor's protocol ID
- mri dwi in adnexal lesions
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2023
- Last updated
- 1 Oct 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Role of Mean Apparent Diffusion Coefficient (ADCmean) Value Measurements to the Ovarian-Adnexal Reporting and Data System (O-RADS) MRI Score in Stratifications of Adnexal Lesions
- ClinicalTrials.gov ID
- NCT07202429
- Acronym / sponsor ID
- mri dwi in adnexal lesions
- Conditions
- Ovarian Neoplasms
- Keywords
- MRI-ORADS, ADC value, Ovarian neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 1 Oct 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.
Evaluation of the impact of adding mean apparent diffusion coefficient (ADC mean) measurements to the Ovarian-Adnexal Imaging Reporting and Data System MRI (O-RADS MRI) scoring for adnexal lesion characterization using a combined O-RADS MRI/ADC mean reading approach.
Detailed description
The patients will be referred from the Gynecology department to the Kasr Al-Ainy Radiology department (Women's imaging unit) based on preliminary ultrasound examination used for cases selection.
Female patients with adnexal lesions on ultrasound were subjected to MRI examination, Standardised MRI sequences will used, including DWI and DCE sequences. blinded to histopathological data, according to the O-RADS MRI scoring system. A quantitative analysis method will applied by placing a ROI on the ADC maps obtained from single-exponential DWI sequences.
Additive role of ADC value will be comparied to O-RADs according to gold standard (pathological examination of adnexal lesions) after excision to correlate results of imaging and pathology.
MRI examination: MR imaging was performed using a 1.5-T magnet using torso coil Diffusion WI: with b values 0, 500, 1000 and 1500 as well as ADC map. Dynamic contrast enhanced study: using 10cc of Gadopentetate dimeglumine and 20ml of saline. Injection is manual. Examination time is 4minutes with 8 series. Scan time for each series: 32secs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Benign Adnexal Lesions | – | Device: MRIDescription: Participants with adnexal lesions that were confirmed as benign on histopathology. Description: Dynamic MRI imaging including diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) measurement, used for lesion characterization with O-RADS scoring. |
| Borderline adnexal lesions | – | Device: MRIDescription: Participants with adnexal lesions that were confirmed as borderline on histopathology. Description: Dynamic MRI imaging including diffusion-weighted imaging (DWI) and ADC measurement, used for lesion characterization with O-RADS scoring. |
| Malignant adnexal lesions | – | Device: MRIDescription: Participants with adnexal lesions that were confirmed as maligannt on histopathology. Description: Dynamic MRI imaging including diffusion-weighted imaging (DWI) and ADC measurement, used for lesion characterization with O-RADS scoring. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- female patients any age with ovarian lesions
Key inclusion criteria (4 listed)
- (1) Female patient any age with at least one adnexal lesion detected by U/S reported as O-RADS3to5.
- (5)If two masses had similar morphologies, the largest mass was included.
Key exclusion criteria (7 listed)
- Female patient any age with adnexal lesions detected by U/S reported as O-RADS1and2.
- Cysts that were deemed to be clearly physiological and less than 3 cm in maximum diameter.
- No histopathological findings or follow-up < one year .
- Previous bilateral adnexectomy.
- Contraindications to MRI examination including
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"Multiparametric MRI of adnexal lesions, including conventional sequences, diffusion-weighted imaging (DWI) with apparent diffusion coefficient (ADC) measurement, and dynamic contrast-enhanced (DCE) MRI. Imaging findings were evaluated using the O-RADS MRI scoring system." | Device | Benign Adnexal Lesions, Borderline adnexal lesions, Malignant adnexal lesions |
Primary outcome
Mean ADC value of adnexal lesions
Time frame: March 2023 to june 2024
Measurement of mean apparent diffusion coefficient (ADCmean) values in adnexal lesions using diffusion-weighted imaging (DWI). Unit of Measure: ADC value (×10-³ mm²/s)
Diagnostic performance of O-RADS MRI + ADC system
Time frame: March 2023 to june 2024
Evaluation of diagnostic performance (sensitivity, specificity, accuracy) of O-RADS MRI scoring combined with ADC values, compared with O-RADS MRI system alone. Unit of Measure: Percentage (%)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 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.
Lamia Salah Eldin, M.D principal investigator
kasr-alainy cairo university
Manar Alaa Eldin Osman, M.D study director
kasr-alainy cairo university
Mohammed Aly Shalaby, M.D study chair
kasr-alainy cairo university
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 Neoplasms, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 1 Oct 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean ADC value of adnexal lesions (time frame: March 2023 to june 2024). The study lists 2 primary outcomes in all. 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 1 Oct 2025.