Breast Masses MRI Volumetry Compared to Post-operative Pathological Volume

NCT ID: NCT07268300

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-10-01

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.

Conditions

Breast Masses

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

study group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Esraa kotb

residant doctor at Assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

BMRI-PATHVOL-TRIAL25

Identifier Type: -

Identifier Source: org_study_id