Breast Cancer Molecular Subtypes and Skeletal Metastases Patterns on Bone Scintigraphy

August 2, 2026 updated by: Reham Soltan Mohamed, Sohag University

Association of Breast Cancer Molecular Subtypes With Patterns of Skeletal Metastases on Bone Scintigraphy

The goal of this observational study is to evaluate the association between different molecular subtypes of breast cancer and their specific patterns of skeletal metastases on Technetium-99m MDP bone scintigraphy.

The study will include adult male and female patients aged 18 to 80 years with histopathologically confirmed breast cancer who are referred for whole-body bone scintigraphy.

The main questions it aims to answer are:

What is the frequency and pattern of skeletal metastases across different breast cancer molecular subtypes (Luminal A, Luminal B, HER2-enriched, and Triple-Negative) on bone scintigraphy?
How do nuclear medicine scintigraphic findings correlate with tumor biomarker profiles? Researchers will compare imaging patterns among the different molecular subtype groups to determine if specific biomarker profiles correlate with distinct bone metastatic behaviors.

Study Overview

Status

Not yet recruiting

Conditions

Breast Cancer

Study Type

Observational

Enrollment (Estimated)

100

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

Name: Reham S Mohamed
Phone Number: +20 1064214014
Email: Reham.Soltan@med.sohag.edu.eg

Study Locations

Egypt
- - Sohag, Egypt
    - Faculty of Medicine Sohag University

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

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

The study will include 100 patients diagnosed with histologically proven breast cancer who are referred to the Nuclear Medicine Department for Technetium-99m labeled diphosphonates (Tc99m-MDP )whole-body bone scintigraphy.

Description

Inclusion Criteria:

Patients of both sexes (females and males) with a confirmed histopathological diagnosis of breast cancer, including all major histological types: Invasive Ductal Carcinoma (IDC), Invasive Lobular Carcinoma (ILC), other mixed or less common epithelial variants.
Patient's age ranging from 18 to 80 years.
Available immunohistochemical (IHC) profiles from the primary breast tumor biopsy or surgery, covering all molecular subtypes including; Luminal A: (ER-positive, PR-positive, HER2-negative, and low Ki-67 index). Luminal B: (ER-positive, PR-variable, HER2-variable "either positive or negative", and high Ki-67 index). HER2-enriched: (ER-negative, PR-negative, and HER2-positive). Triple-Negative breast cancer (TNBC): (no ER, PR or HER2 expression).
Patients referred for bone scintigraphy as part of initial staging, follow-up, or due to clinical suspicion of bone metastasis.

Exclusion Criteria:

Patients with other primary malignancies (to avoid confusion regarding the origin of bone metastases).
Patients with incomplete medical records or unavailable immunohistochemical data.
Pregnant female patients.
Patients aged under 18 years old.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of skeletal metastases on Tc-99m MDP whole-body bone scintigraphy. Time Frame: Baseline	Number of participants with skeletal metastases detected by Tc-99m MDP whole-body bone scintigraphy according to breast cancer molecular subtype.	Baseline
Anatomical distribution of skeletal metastases. Time Frame: Baseline	Anatomical distribution of skeletal metastases (axial skeleton, appendicular skeleton or mixed) according to breast cancer molecular subtype.	Baseline

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

Principal Investigator: Reham S Mohamed, Faculty of Medicine Sohag University

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)

August 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

July 26, 2026

First Submitted That Met QC Criteria

August 2, 2026

First Posted (Actual)

August 6, 2026

Study Record Updates

Last Update Posted (Actual)