Breast CancerNCT03173469
Preoperative Breast Magnetic Resonance Imaging for Patients Undergoing Mammoplasty
An observational study of Breast Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
all female with operable breast cancer seeking health care at general surgery department Assiut university hospitals,and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography, will undergo MRI breast, and see if MRI finding will change decision of the… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- magnetic resonance imaging of breast
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2017to 15 Aug 2018
- 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
- Child, Adult, Older adult
Study population: All female with operable breast cancer who candidate fot therapeutic mammoplasty,Sample size was calculated using G power, it is 40 patients.
Who may be able to join
- Female patient with operable breast cancer (stage 1 and 2 ) Patient meet the criteria of therapeutic mammoplasty
Who cannot join
- Inoperable breast cancer (stage 3 and 4) Breast cancer size > 4 cm in diameter Previous radiotherapy Local recurrence after previous breast conservation surgery Male breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Preoperative Breast Magnetic Resonance Imaging for Surgical Decision in Patients Undergoing Therapeutic Mammoplasty
all female with operable breast cancer seeking health care at general surgery department Assiut university hospitals,and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography, will undergo MRI breast, and see if MRI finding will change decision of the surgery.
Read the detailed description
- Study Setting: Assiut university hospital, general surgery department (C unit )
- Study subjects: all female with operable breast cancer seeking health care at general surgery department and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography.
The size, number, and location of breast cancer lesions were identified on US and mammography.
Also size, number, location, pattern of enhancement and presence or absence of intraductal component will be evaluated by preoperative MRI.
The surgical plane will be decided based on US and mammography findings. The final decision will be based on MRI findings. When the initial surgical decision was the same as final decision the patient will be assigned to the unchanged group.
However, if the final decision differed from the initial surgical decision the patient will be assigned to the changed group.
- Conditions
- Breast Cancer
- Being tested
- magnetic resonance imaging of breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging of breastOther
all patients will undergo preoperative MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients whom MRI finding that will change the decision of surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start15 Jul 2017
- Primary completion15 Jun 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A maher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173469
- Sponsor's protocol ID
- MRIbreast
- Status last verified
- Jun 2019
- First submitted
- 30 May 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Preoperative Breast Magnetic Resonance Imaging for Surgical Decision in Patients Undergoing Therapeutic Mammoplasty
- ClinicalTrials.gov ID
- NCT03173469
- Acronym / sponsor ID
- MRIbreast
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 1 Jun 2017 (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.
all female with operable breast cancer seeking health care at general surgery department Assiut university hospitals,and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography, will undergo MRI breast, and see if MRI finding will change decision of the surgery.
Detailed description
- Study Setting: Assiut university hospital, general surgery department (C unit )
- Study subjects: all female with operable breast cancer seeking health care at general surgery department and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography.
The size, number, and location of breast cancer lesions were identified on US and mammography.
Also size, number, location, pattern of enhancement and presence or absence of intraductal component will be evaluated by preoperative MRI.
The surgical plane will be decided based on US and mammography findings. The final decision will be based on MRI findings. When the initial surgical decision was the same as final decision the patient will be assigned to the unchanged group.
However, if the final decision differed from the initial surgical decision the patient will be assigned to the changed group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- All female with operable breast cancer who candidate fot therapeutic mammoplasty,Sample size was calculated using G power, it is 40 patients.
Key inclusion criteria (1 listed)
- Female patient with operable breast cancer (stage 1 and 2 ) Patient meet the criteria of therapeutic mammoplasty
Key exclusion criteria (1 listed)
- Inoperable breast cancer (stage 3 and 4) Breast cancer size > 4 cm in diameter Previous radiotherapy Local recurrence after previous breast conservation surgery Male breast cancer
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 |
|---|---|---|
| magnetic resonance imaging of breastall patients will undergo preoperative MRI | Other | – |
Primary outcome
percentage of patients whom MRI finding that will change the decision of surgery
Time frame: 1 year
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 25 Jun 2019.
- Individual participant dataSharing planned: No
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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 Breast Cancer, run by Assiut 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 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: finished, as of the sponsor's last update on 25 Jun 2019. 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?
percentage of patients whom MRI finding that will change the decision of surgery (time frame: 1 year). 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 25 Jun 2019.