Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone

NCT06321666 | Active Not Recruiting

• 1 other identifier: IEO 0986
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer; whole body magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan

  Number of patients where disease progression in bone metastases were identified using WB-MRI prior to identification by CT scan

  36 months

Study Arms (1)

WB-MRI and CT Scan

OTHER

CT scan (neck/thorax/abdomen/pelvis) and WB-MRI

Other: WB-MRI

Interventions

WB-MRI OTHER

All patients will undergo a CT scan (neck/thorax/abdomen/pelvis) and a WB-MRI

WB-MRI and CT Scan

Eligibility Criteria

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

You may qualify if:

• Histological diagnosis of breast cancer
• Single or multiple bone metastases (additional extraosseous or non-bony metastatic disease permitted)
• Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)
• Aged 18 and over
• Life expectancy of over 6 months
• No current active malignancy other than breast cancer

You may not qualify if:

• Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis
• Absolute contraindication to MRI studies, CT scans, bone scans or FDG-PET/CT
• Pregnancy
• Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient as part of the informed consent process.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

IEO Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Giuseppe Petralia, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: September 12, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

IT (1)