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

April 5, 2026 updated by: Seham Sharef Eid Ahmed, Assiut University

Diagnostic Performance of F18-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

Study Overview

Status

Not yet recruiting

Conditions

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 .

Study Type

Observational

Enrollment (Estimated)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with metastatic breast cancer

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast cancer Patients
18 FDG PET CT scan for metastatic breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Hebatallah Ahmed Abdelraof, Professor, nuclear medicine unit Assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssuitUfacultyProtocol19962026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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