Breast Masses MRI Volumetry Compared to Post-operative Pathological Volume

NCT07268300 | Not Yet Recruiting

• 1 other identifier: BMRI-PATHVOL-TRIAL25
• Study Type: observational
• Target: 59
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Accuracy of MRI volumetry

  Accuracy of MRI volumetry of breast masses in estimating tumor volume

  baseline

Study Arms (1)

study group

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11