NCT06321666

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Breast Cancer

Interventions

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

Timeline

• Start date: 2019-09-12
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-03-20
• Last updated: 2024-03-20

Locations

1 site across 1 country: Italy