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Breast Masses MRI Volumetry Compared to Post-operative Pathological Volume

Breast Masses MRI Volumetry Compared to Post-operative Pathological Volume

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07268300
Enrollment
59
Registered
2025-12-05
Start date
2025-12-01
Completion date
2027-10-01
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Masses

Brief 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. 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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female patients aged between 18 and 65 years old. * BIRADS classification IV, V, or VI * Operable breast cancer. * 1st presentation.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of MRI volumetrybaselineAccuracy of MRI volumetry of breast masses in estimating tumor volume

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026