Complex Adnexal MassesMRI-CAMNCT02694406
MRI Perfusion in Adnexal Masses
An observational study of Complex Adnexal Masses, run by Assiut University at 2 sites in Egypt.
Trial summary
As ovarian cancer is characterized by an anarchic neovascularization resulting in a wide number of immature microvessels. These vessels are characterized by a lack of coverage by pericytes and the higher expression of one of the receptors of Vascular Endothelial Growth Factor on both endothelial and epithelial cells… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Complex Adnexal Masses
- What is being tested?
- MRI perfusion
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- Jul 2015to 1 Dec 2017
- 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: patients with adenxal masses
Who may be able to join
- complex adnexal mass
- patient fit for surgery
Who cannot join
- any general contraindication to MRI
- severely ill patients
- those with claustrophobia.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Added Value of MRI Perfusion in Evaluation of Complex Adnexal Masses
As ovarian cancer is characterized by an anarchic neovascularization resulting in a wide number of immature microvessels. These vessels are characterized by a lack of coverage by pericytes and the higher expression of one of the receptors of Vascular Endothelial Growth Factor on both endothelial and epithelial cells of ovarian cystadenocarcinomas. These physio pathogenic characteristics have been demonstrated to be in line with variations of MR perfusion parameters.
Unlike many lesions that occur in other parts of the body, biopsy should not be performed in adnexal masses that demonstrate no evidence of peritoneal disease because it may cause spillage of cystic contents, potentially leading to iatrogenic up-staging of what may have been a malignant tumor that was limited.
- Conditions
- Complex Adnexal Masses
- Being tested
- MRI perfusion
- Keywords
- Diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI perfusionDevice
contrast-enhanced MR imaging including perfusion weighted imaging (PWI)
What is being measured
The primary outcome is the main question the study is designed to answer.
detect the number of malignant adnexal masses
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJul 2015
- Primary completion1 Nov 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Adnexal MassesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694406
- Sponsor's protocol ID
- MRI-CAM
- Acronym
- MRI-CAM
- Status last verified
- Jun 2018
- First submitted
- 24 Feb 2016
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of MRI Perfusion in Evaluation of Complex Adnexal Masses
- ClinicalTrials.gov ID
- NCT02694406
- Acronym / sponsor ID
- MRI-CAM / MRI-CAM
- Conditions
- Complex Adnexal Masses
- Keywords
- Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 29 Feb 2016 (estimated)
- 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.
As ovarian cancer is characterized by an anarchic neovascularization resulting in a wide number of immature microvessels. These vessels are characterized by a lack of coverage by pericytes and the higher expression of one of the receptors of Vascular Endothelial Growth Factor on both endothelial and epithelial cells of ovarian cystadenocarcinomas. These physio pathogenic characteristics have been demonstrated to be in line with variations of MR perfusion parameters.
Unlike many lesions that occur in other parts of the body, biopsy should not be performed in adnexal masses that demonstrate no evidence of peritoneal disease because it may cause spillage of cystic contents, potentially leading to iatrogenic up-staging of what may have been a malignant tumor that was limited.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with adenxal masses
Key inclusion criteria (2 listed)
- complex adnexal mass
- patient fit for surgery
Key exclusion criteria (3 listed)
- any general contraindication to MRI
- severely ill patients
- those with claustrophobia.
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 perfusioncontrast-enhanced MR imaging including perfusion weighted imaging (PWI) | Device | – |
Primary outcome
detect the number of malignant adnexal masses
Time frame: 2 weeks
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 27 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Complex Adnexal Masses
Recruiting
MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.
Ovarian Cancer, Ovarian Mass
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Adnexal Masses, run by Assiut University at 2 sites 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 2 inclusion and 3 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
detect the number of malignant adnexal masses (time frame: 2 weeks). 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 27 Jun 2018.