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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07523516
Enrollment
97
Registered
2026-04-13
Start date
2026-04-01
Completion date
2029-04-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer (Locally Advanced or Metastatic)

Keywords

breast cancer, metastatic, CE-CT

Brief summary

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

Detailed description

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 .

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Inclusion criteria: 1. Patients with pathologically proven breast cancer 2. Metastatic breast cancer proved by pathology or radiological modalities. 3. Interval between 18F-FDG PET/CT and CE-CT from one to three weeks. 2.

Exclusion criteria

1. Patients with known concomitant malignancy 2. Patients receive systemic treatment chemotherapy or radiotherapy between 18F-FDG PET/CT and CE-CT.

Design outcomes

Primary

MeasureTime frameDescription
Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.12 monthsComparison between 18F-FDG PET/CT and CT in detecting distant metastases.

Secondary

MeasureTime frameDescription
Early staging and clinical management of breast cancer in attempt to improve survival and quality of life12 monthsEarly staging and clinical management of breast cancer in attempt to improve survival and quality of life

Contacts

CONTACTSeham Sharef Eid, Master's degree
Seham.14224009@med.aun.edu.eg00201097515105
PRINCIPAL_INVESTIGATORHebatallah Ahmed Abdelraof, Professor

nuclear medicine unit Assiut university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026