Ovarian NeoplasmsNCT05769205
MRI in Ovarian Tumors
A study testing MRI in people with Ovarian Neoplasms, run by Assiut University.
Trial summary
Role of multi paramrtric MRI and MRI perfusion in indetermint ovarian lesions by using ORADS MRI 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- -
Who cannot join
- females with known benign ovarian masses
Trial locations and contacts
No sites are listed yet.
Mostafa Hashem contact
About this study
Official title: Role of Multi Paramertic MRI and MRI Perfusion in Indetermint Ovarian Lesions by Using ORADS MRI
Role of multi paramrtric MRI and MRI perfusion in indetermint ovarian lesions by using ORADS MRI
Read the detailed description
Aim of study the purpose of this study is to investigate the capabilities of multi parametric MRI including DCE perfusion and DWI to discriminate between benign and malignant ovarian masses .
- Conditions
- Ovarian Neoplasms
- Being tested
- MRI
- 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
MRI with contrast
| Study group | Role | What they receive |
|---|---|---|
| female with ovarian masses | Experimental | MRI with contrast according to the kidney function test of the patients Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI in ovarian tumors
Role of parametric MRI in determint ovarian lesions by using ORADS MRI
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 posted15 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- females with ovarian masses
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- principle investigator
- Responsible party
- Principal investigator, Maryam Farouk Mahmoud Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769205
- Sponsor's protocol ID
- MRI in ovarian tumors
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel RK, Garg A, Dixit R, Gandhi G, Khurana N. The role of "penumbra sign" and diffusion-weighted imaging in adnexal masses: do they provide a clue in differentiating tubo-ovarian abscess from ovarian malignancy? Pol J Radiol. 2021 Dec 15;86:e661-e671. doi: 10.5114/pjr.2021.111986. eCollection 2021.
PubMed 35059059
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Multi Paramertic MRI and MRI Perfusion in Indetermint Ovarian Lesions by Using ORADS MRI
- ClinicalTrials.gov ID
- NCT05769205
- Acronym / sponsor ID
- MRI in ovarian tumors
- Conditions
- Ovarian Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- principle investigator
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Mar 2023 (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.
Role of multi paramrtric MRI and MRI perfusion in indetermint ovarian lesions by using ORADS MRI
Detailed description
Aim of study the purpose of this study is to investigate the capabilities of multi parametric MRI including DCE perfusion and DWI to discriminate between benign and malignant ovarian masses .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- females with ovarian masses
| Arm | Type | Receives |
|---|---|---|
| female with ovarian masses | Experimental | Device: MRIMRI with contrast according to the kidney function test of the patients |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- females with known benign ovarian masses
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 |
|---|---|---|
| MRIMRI with contrast | Device | female with ovarian masses |
Primary outcome
MRI in ovarian tumors
Time frame: 2 years
Role of parametric MRI in determint ovarian lesions by using ORADS MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 35059059Patel RK, Garg A, Dixit R, Gandhi G, Khurana N. The role of "penumbra sign" and diffusion-weighted imaging in adnexal masses: do they provide a clue in differentiating tubo-ovarian abscess from ovarian malignancy? Pol J Radiol. 2021 Dec 15;86:e661-e671. doi: 10.5114/pjr.2021.111986. eCollection 2021.
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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.
Mostafa Hashem contact
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Ovarian Neoplasms, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maryam Farouk Sayed (01064353498, Faroukmariam54@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI in ovarian tumors (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05769205, which also lists 1 linked publication.
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 15 Mar 2023.