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临床试验/NCT07268300
NCT07268300尚未招募不适用

Breast Masses MRI Volumetry Compared to Post-operative Pathological Volume

Assiut University0 个研究点目标入组 59 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
59
主要终点
Accuracy of MRI volumetry

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Accuracy of MRI volumetry

时间窗: baseline

Accuracy of MRI volumetry of breast masses in estimating tumor volume

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esraa kotb

residant doctor at Assiut university hospital

Assiut University

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