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

Trial Title: Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone

NCT ID: NCT06321666

Condition: Metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Metastatic breast cancer
whole body magnetic resonance imaging

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: WB-MRI
Description: All patients will undergo a CT scan (neck/thorax/abdomen/pelvis) and a WB-MRI
Arm group label: WB-MRI and CT Scan

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: IEO Istituto Europeo di Oncologia

Address:
City: Milan
Zip: 20141
Country: Italy

Start date: September 12, 2019

Completion date: December 31, 2024

Lead sponsor:
Agency: European Institute of Oncology
Agency class: Other

Source: European Institute of Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06321666