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Clinical Trials/NCT07750340
NCT07750340Not yet recruitingNot Applicable

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

Sohag University1 site in 1 country100 target enrollmentStarted: August 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Locations
1
Primary Endpoint
Presence of skeletal metastases on Tc-99m MDP whole-body bone scintigraphy.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Reham Soltan Mohamed

Resident Physician

Sohag University

Study Sites (1)

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