Carcinoma in SituNCT06744140
Role of MRI Breast in Detection of Ductal Carcinoma in Situ
An observational study of Carcinoma in Situ, run by Superior University at 1 site in Pakistan.
Trial summary
"This study investigates the role of Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma in situ (DCIS) in high-risk breast cancer patients. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carcinoma in Situ
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- How many people
- 35 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2024to 21 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: To Evaluate the breast Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma In Situ (DCIS) lesions among high-risk breast cancer patients while keeping the histopathology as a GOLD standard
Who may be able to join
- High-risk breast cancer patients with a family history of breast cancer or genetic predispositions (e.g., BRCA mutations).
- Patients aged 30-65 years.
- Patients willing to undergo breast MRI screening for DCIS detection.
Who cannot join
- Patients with contraindications to MRI imaging (e.g., pacemakers, claustrophobia).
- Patients with a history of prior breast surgery or interventions that may interfere with imaging interpretation.
Trial locations and contacts
1 site in 1 country.
About this study
"This study investigates the role of Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma in situ (DCIS) in high-risk breast cancer patients.
Read the detailed description
Improved detection rates of DCIS in high-risk patients. Enhanced diagnostic accuracy, reducing false positives and negatives. Ductal Carcinoma in situ (DCIS) is a non-invasive breast cancer where abnormal cells are confined to the milk ducts.
The Breast Imaging Reporting and Data System (BI-RADS) is a standardized scoring system used to classify breast imaging findings. Scores range from 0 (incomplete) to 6 (known biopsy-proven malignancy)."
- Conditions
- Carcinoma in Situ
- Being tested
- Magnetic Resonance Imaging (MRI)
- Medical subject headings
- Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
To Evaluate the breast Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma In Situ (DCIS) lesions among high-risk breast cancer patients while keeping the histopathology as a GOLD standard
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity & specificity
sensitivity \& specificity of MRI in detecting DCIS
Measured: 12 Months
BIRADS scores
BIRADS scores will be used to evaluate the diagnostic accuracy of MRI in detecting DCIS
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 start15 Feb 2024
- Primary completion1 Jul 2024
- Study completion21 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma in SituStudies 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
- Retrospective
- Enrolment
- 35 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
- NCT06744140
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/018
- 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
- Individual data sharing
- 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
- Role of MRI Breast in Detection of Ductal Carcinoma in Situ
- ClinicalTrials.gov ID
- NCT06744140
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/018
- Conditions
- Carcinoma in Situ
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 21 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 investigates the role of Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma in situ (DCIS) in high-risk breast cancer patients.
Detailed description
Improved detection rates of DCIS in high-risk patients. Enhanced diagnostic accuracy, reducing false positives and negatives. Ductal Carcinoma in situ (DCIS) is a non-invasive breast cancer where abnormal cells are confined to the milk ducts.
The Breast Imaging Reporting and Data System (BI-RADS) is a standardized scoring system used to classify breast imaging findings. Scores range from 0 (incomplete) to 6 (known biopsy-proven malignancy)."
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- To Evaluate the breast Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma In Situ (DCIS) lesions among high-risk breast cancer patients while keeping the histopathology as a GOLD standard
Key inclusion criteria (3 listed)
- High-risk breast cancer patients with a family history of breast cancer or genetic predispositions (e.g., BRCA mutations).
- Patients aged 30-65 years.
- Patients willing to undergo breast MRI screening for DCIS detection.
Key exclusion criteria (2 listed)
- Patients with contraindications to MRI imaging (e.g., pacemakers, claustrophobia).
- Patients with a history of prior breast surgery or interventions that may interfere with imaging interpretation.
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 (MRI)To Evaluate the breast Magnetic Resonance Imaging (MRI) in detecting Ductal Carcinoma In Situ (DCIS) lesions among high-risk breast cancer patients while keeping the histopathology as a GOLD standard | Diagnostic test | – |
Primary outcome
sensitivity & specificity
Time frame: 12 Months
sensitivity \& specificity of MRI in detecting DCIS
BIRADS scores
Time frame: 12 Months
BIRADS scores will be used to evaluate the diagnostic accuracy of MRI in detecting DCIS
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.
- 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 Carcinoma in Situ, 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 3 inclusion and 2 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 & specificity (time frame: 12 Months). The study lists 2 primary outcomes in all. 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.