Breast CancerNCT06494865
" Role of Diffusion Weighted Image in the Diagnosis and Follow up of Breast Cancer"
An observational study of Breast Cancer, run by Sohag University.
Trial summary
Breast MRI has become an important tool for breast cancer detection and characterization.Contrast enhanced MRI(CE-MRI) is currently the most sensitive detection technique for diagnosis of breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI device
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Dec 2024
- 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 18 to 70 years
- Women only
- Adult, Older adult
Study population: Female gender * Age more than 18 years * Patients presented with breast lump * Pateints with recurrent breast cancer following chemotherapy or radiotherapy sessions.
Who may be able to join
- * Female gender
- Age more than 18 years
- Patients presented with breast lump
- Patients with recurrent breast cancer following chemotherapy or radiotherapy sessions.
Who cannot join
- Male gender
- Age younger than 18 years
- Patients with recent breast trauma in the same diseased breast within the last 6 months
- Lactating female presented with acute symptoms as trauma or breast abscess
- Contraindication to perform MRI examination .these include : Cardiac pacemaker -Metallic aneurysm clips
Trial locations and contacts
No sites are listed yet.
Medhat I Mohammed, professor contact
About this study
Breast MRI has become an important tool for breast cancer detection and characterization.Contrast enhanced MRI(CE-MRI) is currently the most sensitive detection technique for diagnosis of breast cancer.
Read the detailed description
Most of the lesions that occur in the breast are benign lesions. It is important to recognize benign lesions and distinguish them from breast cancer.
Nowadays sonomammography still represents the primary imaging modality utilized for breast cancer screening and diagnosis.
Breast MRI has become an important tool for breast cancer detection and characterization.Contrast enhanced MRI(CE-MRI) is currently the most sensitive detection technique for diagnosis of breast cancer.Diffusion weighted imaging provides micro-structural informations regadrding the diffusion of the water molecules in the tissue cellularity and tissue structure by using the quantitive analysis with the apparent diffusion coefficient (ADC) values.
Using Diffusion weighted imaging (DWI) combined to MRI is helpful to distinguish malignant versus benign breast lesions and it also may reduce the number of unnecessarily breast biopsies.
- Conditions
- Breast Cancer
- Being tested
- MRI device
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI deviceDevice
Standered breast coils with small field of veiw and thin sections will be used for the examinatio.
MRI breast including Axial T1WI, T2WI Stir contrast DWI and Stir sagittal T1WI with contrast traction and subtraction
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of correlated false positive results of MRI DWI for the lesion with the positive results by histopathology.
evaluation of the lesion with MRI DWI and histopathology for detect rate of false posive results
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Ashraf Ibrahim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494865
- Sponsor's protocol ID
- soh-Med-24-06-23MS
- Status last verified
- Aug 2024
- First submitted
- 2 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stachs A, Stubert J, Reimer T, Hartmann S. Benign Breast Disease in Women. Dtsch Arztebl Int. 2019 Aug 9;116(33-34):565-574. doi: 10.3238/arztebl.2019.0565.
PubMed 31554551Butti R, Das S, Gunasekaran VP, Yadav AS, Kumar D, Kundu GC. Receptor tyrosine kinases (RTKs) in breast cancer: signaling, therapeutic implications and challenges. Mol Cancer. 2018 Feb 19;17(1):34. doi: 10.1186/s12943-018-0797-x.
PubMed 29455658Shi RY, Yao QY, Wu LM, Xu JR. Breast Lesions: Diagnosis Using Diffusion Weighted Imaging at 1.5T and 3.0T-Systematic Review and Meta-analysis. Clin Breast Cancer. 2018 Jun;18(3):e305-e320. doi: 10.1016/j.clbc.2017.06.011. Epub 2017 Jul 5.
PubMed 28802529Yilmaz E, Sari O, Yilmaz A, Ucar N, Aslan A, Inan I, Parlakkilic UT. Diffusion-Weighted Imaging for the Discrimination of Benign and Malignant Breast Masses; Utility of ADC and Relative ADC. J Belg Soc Radiol. 2018 Feb 7;102(1):24. doi: 10.5334/jbsr.1258.
PubMed 30039037
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Role of Diffusion Weighted Image in the Diagnosis and Follow up of Breast Cancer"
- ClinicalTrials.gov ID
- NCT06494865
- Acronym / sponsor ID
- soh-Med-24-06-23MS
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 10 Jul 2024 (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.
Breast MRI has become an important tool for breast cancer detection and characterization.Contrast enhanced MRI(CE-MRI) is currently the most sensitive detection technique for diagnosis of breast cancer.
Detailed description
Most of the lesions that occur in the breast are benign lesions. It is important to recognize benign lesions and distinguish them from breast cancer.
Nowadays sonomammography still represents the primary imaging modality utilized for breast cancer screening and diagnosis.
Breast MRI has become an important tool for breast cancer detection and characterization.Contrast enhanced MRI(CE-MRI) is currently the most sensitive detection technique for diagnosis of breast cancer.Diffusion weighted imaging provides micro-structural informations regadrding the diffusion of the water molecules in the tissue cellularity and tissue structure by using the quantitive analysis with the apparent diffusion coefficient (ADC) values.
Using Diffusion weighted imaging (DWI) combined to MRI is helpful to distinguish malignant versus benign breast lesions and it also may reduce the number of unnecessarily breast biopsies.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Female gender * Age more than 18 years * Patients presented with breast lump * Pateints with recurrent breast cancer following chemotherapy or radiotherapy sessions.
Key inclusion criteria (4 listed)
- * Female gender
Key exclusion criteria (5 listed)
- Male gender
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 deviceStandered breast coils with small field of veiw and thin sections will be used for the examinatio. MRI breast including Axial T1WI, T2WI Stir contrast DWI and Stir sagittal T1WI with contrast traction and subtraction | Device | – |
Primary outcome
Rate of correlated false positive results of MRI DWI for the lesion with the positive results by histopathology.
Time frame: 6 months
evaluation of the lesion with MRI DWI and histopathology for detect rate of false posive results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 31554551Stachs A, Stubert J, Reimer T, Hartmann S. Benign Breast Disease in Women. Dtsch Arztebl Int. 2019 Aug 9;116(33-34):565-574. doi: 10.3238/arztebl.2019.0565.
- Background: PubMed 29455658Butti R, Das S, Gunasekaran VP, Yadav AS, Kumar D, Kundu GC. Receptor tyrosine kinases (RTKs) in breast cancer: signaling, therapeutic implications and challenges. Mol Cancer. 2018 Feb 19;17(1):34. doi: 10.1186/s12943-018-0797-x.
- Background: PubMed 28802529Shi RY, Yao QY, Wu LM, Xu JR. Breast Lesions: Diagnosis Using Diffusion Weighted Imaging at 1.5T and 3.0T-Systematic Review and Meta-analysis. Clin Breast Cancer. 2018 Jun;18(3):e305-e320. doi: 10.1016/j.clbc.2017.06.011. Epub 2017 Jul 5.
- Background: PubMed 30039037Yilmaz E, Sari O, Yilmaz A, Ucar N, Aslan A, Inan I, Parlakkilic UT. Diffusion-Weighted Imaging for the Discrimination of Benign and Malignant Breast Masses; Utility of ADC and Relative ADC. J Belg Soc Radiol. 2018 Feb 7;102(1):24. doi: 10.5334/jbsr.1258.
- Individual participant dataSharing planned: Undecided
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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.
Medhat I Mohammed, professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sohag 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 4 inclusion and 5 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 7 Aug 2024. 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 Mennatullah A Ibrahim, resident (01015003865, menaashraf@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of correlated false positive results of MRI DWI for the lesion with the positive results by histopathology. (time frame: 6 months). 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 NCT06494865, which also lists 4 linked publications.
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 7 Aug 2024.