Breast MassesNCT07268300
Breast Masses MRI Volumetry Compared to Post-operative Pathological Volume
An observational study of Breast Masses, run by Assiut University.
Trial summary
Breast cancer is one of the most common malignancies afflicting women worldwide 1. Tumor size is important prognostic factor, its accurate measurement is essential for formulating surgery and chemotherapy plans. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Masses
- Type of treatment
- Injection or infusion
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Oct 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged between 18 and 65 years old.BIRADS classification IV, V, or VI with Operable breast cancer.
Who may be able to join
- Female patients aged between 18 and 65 years old.
- BIRADS classification IV, V, or VI
- Operable breast cancer.
- 1st presentation.
Who cannot join
- Patients with contraindication for MRI imaging including heart pacemaker
- Patients with contrast media allergy.
- Prior history of breast cancer in the same breast with recurrence.
- Inflammatory carcinoma.
- Paget disease of the nipple
About this study
Breast cancer is one of the most common malignancies afflicting women worldwide 1.
Tumor size is important prognostic factor, its accurate measurement is essential for formulating surgery and chemotherapy plans. Additionally monitoring the change of tumor volume during treatment is an important for response evaluation criteria in solid tumors (RECIST) 1.
Read more
Typically, breast tumor size is reported from diameter measurements, using the unidimensional response evaluation criteria in solid tumors (RECIST) or the bidimensional WHO criteria. Both caliper techniques are widely employed methods for their simplicity 2. However, may be less sensitive than 3D volumetric measurement 3.
Breast cancers are less well circumscribed and more inhomogeneous on their border than benign lesions 2 and tumor necrosis correlated with tumor grade and aggressiveness is technically challenging while measuring tumor 1.
Measurements of tumor volume is more accurate than diameter and thus more sensitive to tumor size changes in response to treatment. 3D volume measurements more accurately capture the extent of irregularly shaped tumors, multifocality, and diffuse shrinkage of lesions during treatment 3.
Magnetic resonance imaging (MRI) is high resolution, inherent three-dimensionality and able to quantify tumor size 4,5. It is superior to mammography, sonography, and examination for revealing tumor extent in the breast and more accurately reflect the presence and size of residual disease after chemotherapy 3.
Previous studies investigated tumor size measured by the longest diameter on MRI agree with those on pathology 3.
Also 3D tumor volume correlation with those of other pathology has been investigated for was investigated in breast, prostate and pleural cancers 6-8 Our aim is to investigate CE-MRI tumor volume compared to pathology size.
- Conditions
- Breast Masses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | Female patients aged between 18 and 65 years old. BIRADS classification IV, V, or VI with Operable breast cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of MRI volumetry
Accuracy of MRI volumetry of breast masses in estimating tumor volume
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa kotb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268300
- Sponsor's protocol ID
- BMRI-PATHVOL-TRIAL25
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Masses MRI Volumetry Compared to Post-operative Pathological Volume
- ClinicalTrials.gov ID
- NCT07268300
- Acronym / sponsor ID
- BMRI-PATHVOL-TRIAL25
- Conditions
- Breast Masses
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 5 Dec 2025 (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 cancer is one of the most common malignancies afflicting women worldwide 1.
Tumor size is important prognostic factor, its accurate measurement is essential for formulating surgery and chemotherapy plans. Additionally monitoring the change of tumor volume during treatment is an important for response evaluation criteria in solid tumors (RECIST) 1.
Typically, breast tumor size is reported from diameter measurements, using the unidimensional response evaluation criteria in solid tumors (RECIST) or the bidimensional WHO criteria. Both caliper techniques are widely employed methods for their simplicity 2. However, may be less sensitive than 3D volumetric measurement 3.
Breast cancers are less well circumscribed and more inhomogeneous on their border than benign lesions 2 and tumor necrosis correlated with tumor grade and aggressiveness is technically challenging while measuring tumor 1.
Measurements of tumor volume is more accurate than diameter and thus more sensitive to tumor size changes in response to treatment. 3D volume measurements more accurately capture the extent of irregularly shaped tumors, multifocality, and diffuse shrinkage of lesions during treatment 3.
Magnetic resonance imaging (MRI) is high resolution, inherent three-dimensionality and able to quantify tumor size 4,5. It is superior to mammography, sonography, and examination for revealing tumor extent in the breast and more accurately reflect the presence and size of residual disease after chemotherapy 3.
Previous studies investigated tumor size measured by the longest diameter on MRI agree with those on pathology 3.
Also 3D tumor volume correlation with those of other pathology has been investigated for was investigated in breast, prostate and pleural cancers 6-8 Our aim is to investigate CE-MRI tumor volume compared to pathology size.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Female patients aged between 18 and 65 years old. BIRADS classification IV, V, or VI with Operable breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged between 18 and 65 years old.BIRADS classification IV, V, or VI with Operable breast cancer.
Key inclusion criteria (4 listed)
- Female patients aged between 18 and 65 years old.
- BIRADS classification IV, V, or VI
- Operable breast cancer.
- 1st presentation.
Key exclusion criteria (5 listed)
- Patients with contraindication for MRI imaging including heart pacemaker
- Patients with contrast media allergy.
- Prior history of breast cancer in the same breast with recurrence.
- Inflammatory carcinoma.
- Paget disease of the nipple
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of MRI volumetry
Time frame: baseline
Accuracy of MRI volumetry of breast masses in estimating tumor volume
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 5 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Masses, run by Assiut 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: opening soon, as of the sponsor's last update on 5 Dec 2025. 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?
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?
Accuracy of MRI volumetry (time frame: baseline). 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 5 Dec 2025.