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NCT Number: NCT07523516

Diagnostic Performance of 18F-FDG PET/CT in Detecting Distant Metastases in Breast Cancer

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

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Key information

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 12 months

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

Secondary outcomes

  1. Early staging and clinical management of breast cancer in attempt to improve survival and quality of life

    Time frame: 12 months

    Early staging and clinical management of breast cancer in attempt to improve survival and quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Seham Sharef Eid, Master's degree

CONTACT

[email protected]

00201097515105

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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