Spots Global Cancer Trial Database for Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone

Study Description

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.

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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