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临床试验/NCT05064475
NCT05064475Unknown不适用

Correlation Between Petct Based Quantitative Parameters and CA 15.3 in Suspected Recurrent Breast Cancer

Assiut University0 个研究点目标入组 72 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
72
主要终点
identification of recurrence

研究概览

简要总结

Worldwide, breast cancer (BC) is the most frequent type of cancer in women yet, it is associated with relatively lower mortality rates, as it ranks fifth in cancer-related deaths overall, which is attributed to evolution in the treatment of recurrent and metastatic lesions, especially when these lesions were detected early . BC recurrence can occur even 15 years after primary treatment.

详细描述

life-long routine monitoring is mandatory. Although histopathologic confirmation is the definitive diagnostic method for BC recurrence, it is not always easy to perform as in cases with deeply located or very small-size lesions, or lesion too close to organs or great vessels, making sampling either inaccessible or hazardous. BC recurrence can be assessed using morphological imaging studies or tumor markers. Mammography, ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) are currently the most commonly used morphological imaging methods for detecting breast cancer recurrence. However, both of the two modalities have some restrictions.

Cancer antigen 15-3 (CA 15-3) and carcinoembryonic antigen (CEA) are two tumor markers that are frequently used in the monitoring of BC patients . However, the findings of many studies on these markers in BC follow-up are conflicting.

The introduction of integrated 2-deoxy-2-[18 F] fluoro-D-glucose (18FDG) positron emission tomography (PET) computed tomography (CT), known as PET/CT, has become a helpful tool for this purpose.

PET/CT is the functional imaging tool that can measure increased glucose metabolism in cancer cells by using 18F-FDG. Its ability to identify tumor recurrence before detection of morphologic changes in conventional imaging reflecting its importance in detecting BC recurrence in asymptomatic patients with high tumor markers and negative results of radiological imaging. 18F-FDG PET/CT is frequently used for BC evaluation. However, data on its value in evaluating BC recurrence in patients with elevated tumor markers are limited and unclear

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
Female
接受健康志愿者

入选标准

  • female patient with pathologically proved breast cancer who will be referred to do PET\CT imaging at the nuclear medicine unit, Assiut university hospital due to suspicion of recurrence based on elevated level of tumor marker in the period between October 2021 until the end of the study .

排除标准

  • patients with newly diagnosed BC patients with early stages of BC BC patients with normal serum level of tumor markers

结局指标

主要结局

identification of recurrence

时间窗: 2 years

correlation between PET/CT parameters and the serum level of tumour markers in suspected recurrent BC as well as finding the best cut-off value of tumor markers that can be used in the identification of recurrence

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

SASamy

Salma Ahmed Samy anwar

Assiut University

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