Breast Masses MRI Volumetry Compared to Post-operative Pathological Volume
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Masses. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Accuracy of MRI volumetry [Time frame: baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07268300 · BMRI-PATHVOL-TRIAL25