An observational study in Breast Cancer (Locally Advanced or Metastatic), sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Assiut University · Observational
compare the accuracy and sensitivity of 18F FDG-PET/CT and CE-CT in detecting distant metastases in breast cancer
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.
Malignant cells show higher glucose metabolism and increased glycolytic activity compared to non-malignant cells (10). This high glycolytic activity eases the detection of malignant cells using [18F] FDG-PET/CT) imaging. so, [18F] FDG-PET/CT can detect changes in metabolic activity before morphologic changes can be seen.
However, the exact clinical stage at which PET/CT can be performed with well-balanced cost-effectiveness is uncertain till now .
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 97 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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patients with metastatic breast cancer
Patients with pathologically proven breast cancer
Patients with known concomitant malignancy
18 FDG PET CT scan for metastatic breast cancer
Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.
Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.
Time frame: 12 months
Early staging and clinical management of breast cancer in attempt to improve survival and quality of life
Early staging and clinical management of breast cancer in attempt to improve survival and quality of life
Time frame: 12 months
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Assiut University