Clinical trial NCT06321666: Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone
Official title: Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study MILANO : RESPECT-MI
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer
whole body magnetic resonance imaging
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IEO Istituto Europeo di Oncologia
Study officials:
affiliation: European Institute of Oncology
name: Giuseppe Petralia, MD
role: PRINCIPAL_INVESTIGATOR
References: