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临床试验/NCT07523516
NCT07523516尚未招募不适用

Diagnostic Performance of F18-FDG PET/CT in Detecting Distant Metastases in Breast Cancer

Assiut University0 个研究点目标入组 97 人开始时间: 2026年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
97
主要终点
Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.

研究概览

简要总结

compare the accuracy and sensitivity of 18F FDG-PET/CT and CE-CT in detecting distant metastases in breast cancer

详细描述

Breast cancer is the most common cancer type and the most common cause of death in women worldwide.

Breast cancer patients with large tumours (T3) have a 8.3%-15.1% risk for distant metastasis. Metastatic breast cancer (MBC) is considered an incurable disease with a 5-year overall survival of only 25%.

Effective management of breast cancer requires accurate diagnosis and determination of the extent of the disease to select the most effective treatment approach. Breast cancer is very heterogenous and is characterized by different pathological features, with distinct responses to treatment and differences in long-term patient survival.

Various imaging modalities have been suggested for diagnosing MBC; however, contrast-enhanced computed tomography (CE-CT) and bone scintigraphy are often used in clinical practice. However, CE-CT has low sensitivity for bone metastases and low specificity for liver metastases.

CE-CT and the corresponding response evaluation criteria in solid tumours (RECIST) are methods that assess changes in structural lesions, making it challenging to differentiate between active tumour tissue and scar lesions [18F]-fluorodeoxyglucose-positron emission tomography/computed tomography ([18F] FDG-PET/CT) is a glucose analog transported via glucose transporters into the cells and phosphorylated by hexokinase .FDG follows the same pathway as glucose during the first enzymatic reactions in the cells, but because FDG lacks a hydroxyl group at the C-2 position, it is not metabolized further and is physically trapped in tumor cells at a rate proportional to glucose utilization.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Inclusion criteria:
  • Patients with pathologically proven breast cancer
  • Metastatic breast cancer proved by pathology or radiological modalities.
  • Interval between 18F-FDG PET/CT and CE-CT from one to three weeks.

排除标准

  • Patients with known concomitant malignancy
  • Patients receive systemic treatment chemotherapy or radiotherapy between 18F-FDG PET/CT and CE-CT.

研究组 & 干预措施

Breast cancer Patients

18 FDG PET CT scan for metastatic breast cancer

结局指标

主要结局

Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.

时间窗: 12 months

Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.

次要结局

  • Early staging and clinical management of breast cancer in attempt to improve survival and quality of life(12 months)

研究者

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

Seham Sharef Eid Ahmed

doctor

Assiut University

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