Breast LNNCT06744101
Comparative Evaluation of Diffusion Weighted MRI And Ultrasonography In The Detection of Breast Lesions
An observational study of Breast LN, run by Superior University at 1 site in Pakistan.
Trial summary
This study aims to conduct a comparative evaluation of Diffusion Weighted MRI (DW-MRI) and Ultrasonography (US) in detecting breast lesions. Breast cancer remains a leading cause of cancer-related deaths among women worldwide, necessitating efficient and accurate diagnostic methods. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast LN
- What is being tested?
- Evaluate the effectiveness of Diffusion Weighted MRI (DWI) in detecting breast lesions. and Compare Sensitivity and Specificity of DWI and USG
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Evaluation of Diffusion Weighted MRI And Ultrasonography In The Detection of Breast Lesions
Who may be able to join
- Women with suspected breast lesions
- Breast feeding woman
- Referred for MRI examination.
- Age 18 years or older
- Ability to provide informed consent.
Who cannot join
- Contraindications to MRI or contrast agent
- Previous breast Implant
- Early Pregnancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
563-B peoples colony 1 main satiana road Faisalabad
Faisalābad, Punjab Province
About this study
This study aims to conduct a comparative evaluation of Diffusion Weighted MRI (DW-MRI) and Ultrasonography (US) in detecting breast lesions. Breast cancer remains a leading cause of cancer-related deaths among women worldwide, necessitating efficient and accurate diagnostic methods. Ultrasonography, a commonly used imaging modality, provides valuable insights into breast lesions but has limitations in sensitivity and specificity.
Read the detailed description
Diffusion Weighted MRI, on the other hand, shows potential for higher accuracy in identifying malignant versus benign lesions due to its ability to assess tissue cellularity and integrity non-invasively. This research will involve a specified number of female participants within a defined age range, focusing on the comparative effectiveness, sensitivity, and specificity of DW-MRI and US. The findings are expected to contribute valuable insights into optimizing breast cancer diagnostic protocols, ultimately aiding in earlier detection, better patient outcomes, and possibly reducing the need for invasive biopsy procedures.
- Conditions
- Breast LN
- Being tested
- Evaluate the effectiveness of Diffusion Weighted MRI (DWI) in detecting breast lesions., Compare Sensitivity and Specificity of DWI and USG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate the effectiveness of Diffusion Weighted MRI (DWI) in detecting breast lesions.Radiation
Assess the sensitivity, specificity, and diagnostic accuracy of DWI compared to Ultrasonography (USG) for benign and malignant lesions.
Compare Sensitivity and Specificity of DWI and USGRadiation
Analyze which modality performs better in lesion detection based on sensitivity and specificity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
- Ultrasonography (USG): BI-RADS classification.
- Diffusion Weighted MRI (DWI): Apparent Diffusion Coefficient (ADC) values.
- Scales/Measurements:
- Sensitivity (%):
Formula: (True Positives) ÷ (True Positives + False Negatives) × 100
- Specificity (%):
Formula: (True Negatives) ÷ (True Negatives + False Positives) × 100
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start28 Feb 2024
- Primary completion1 Jul 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast LNStudies of the same condition, open and under way.
- More trials run by Superior 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-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744101
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/013
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Diffusion Weighted MRI And Ultrasonography In The Detection of Breast Lesions
- ClinicalTrials.gov ID
- NCT06744101
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/013
- Conditions
- Breast LN
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 20 Dec 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.
This study aims to conduct a comparative evaluation of Diffusion Weighted MRI (DW-MRI) and Ultrasonography (US) in detecting breast lesions. Breast cancer remains a leading cause of cancer-related deaths among women worldwide, necessitating efficient and accurate diagnostic methods. Ultrasonography, a commonly used imaging modality, provides valuable insights into breast lesions but has limitations in sensitivity and specificity.
Detailed description
Diffusion Weighted MRI, on the other hand, shows potential for higher accuracy in identifying malignant versus benign lesions due to its ability to assess tissue cellularity and integrity non-invasively. This research will involve a specified number of female participants within a defined age range, focusing on the comparative effectiveness, sensitivity, and specificity of DW-MRI and US. The findings are expected to contribute valuable insights into optimizing breast cancer diagnostic protocols, ultimately aiding in earlier detection, better patient outcomes, and possibly reducing the need for invasive biopsy procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Evaluation of Diffusion Weighted MRI And Ultrasonography In The Detection of Breast Lesions
Key inclusion criteria (5 listed)
- Women with suspected breast lesions
- Breast feeding woman
- Referred for MRI examination.
- Age 18 years or older
- Ability to provide informed consent.
Key exclusion criteria (3 listed)
- Contraindications to MRI or contrast agent
- Previous breast Implant
- Early Pregnancy
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 |
|---|---|---|
| Evaluate the effectiveness of Diffusion Weighted MRI (DWI) in detecting breast lesions.Assess the sensitivity, specificity, and diagnostic accuracy of DWI compared to Ultrasonography (USG) for benign and malignant lesions. | Radiation | – |
| Compare Sensitivity and Specificity of DWI and USGAnalyze which modality performs better in lesion detection based on sensitivity and specificity. | Radiation | – |
Primary outcome
Sensitivity and Specificity
Time frame: 12 Months
* Ultrasonography (USG): BI-RADS classification. * Diffusion Weighted MRI (DWI): Apparent Diffusion Coefficient (ADC) values. * Scales/Measurements: * Sensitivity (%): Formula: (True Positives) ÷ (True Positives + False Negatives) × 100 * Specificity (%): Formula: (True Negatives) ÷ (True Negatives + False Positives) × 100
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
Related trials for Breast LN
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
RecruitingPhase 3
TCb vs EC-T in High Risk ER+/HER2- Breast Cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer
RecruitingObservational study
A Prospective Multicenter Study of the TuFEst-LN Model for Axillary Lymph Node Status Assessment in Breast Cancer
Breast Cancer, Axillary Lymph Node Metastasis
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 LN, run by Superior University at 1 site in Pakistan.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Dec 2024. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sensitivity and Specificity (time frame: 12 Months). 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 20 Dec 2024.