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

Metastatic Breast Cancer Clinical Trial

— RESPECT-MI  

Official title:

Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study MILANO : RESPECT-MI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06321666
• Other study ID #: IEO 0986
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 12, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a monocentric study. All patients will undergo assessments by CT and WB-MRI at all time points. - A baseline bone scan or Fluorodeoxyglucose-Position Emission Tomography (FDG-PET) will be performed. - CT scans and WB--MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in section 7.1.3). - At the point of disease progression, a repeat bone scan or FDG-PET/CT will be obtained in addition to the CT and WB-MRI. Participation in the trials ends at the point of disease progression. Patients will be reviewed in outpatient clinic: - At baseline - Every 12 weeks until week 96, with the results of their recent scans. - As with the imaging, the trial visits will change to every 24 weeks after the week 96 visit. At the week 12 and week 36 visits, the patients will undergo a clinical examination and perform a pain thermometer score and Patient Imaging Questionnaire.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Italy	IEO Istituto Europeo di Oncologia	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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