Breast Cancer Molecular Subtypes and Skeletal Metastases Patterns on Bone Scintigraphy

NCT07750340 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-7-10MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Bone Scintigraphy; Molecular Subtypes; Technetium Tc 99m MDP; Bone Metastases; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Presence of skeletal metastases on Tc-99m MDP whole-body bone scintigraphy.

  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.

  Anatomical distribution of skeletal metastases (axial skeleton, appendicular skeleton or mixed) according to breast cancer molecular subtype.

  Baseline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Reham S Mohamed

  Faculty of medicine sohag university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reham S Mohamed

CONTACT

+20 1064214014; Reham.Soltan@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)