Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IEO 1108 | Other Identifier | Comitato Etico degli IRCCS Istituto Europeo di Oncologia e Centro Cardiologico Monzino |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in high-risk populations thanks to the possibility of being able to use a more effective treatment. The primary objective is to evaluate 5-year overall survival (OS) in patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) or high-risk Triple Negative (TN) undergoing surveillance with DWB-MRI.
Breast cancer is the second most common cancer in the world and the most common cancer among women. In these patients, it is not the primary tumor, but its distant metastases that are the main cause of death. Follow-up may vary depending on the hospital or doctor, but the data available in the literature do not show an advantage in terms of survival or quality of life in patients subjected to intensive follow-up. However, the information that physicians have comes from past studies limited by the presence of bias regarding patient characteristics, therapies, follow-up intervals and tests used. In light of the better understanding of biology, breast cancer is no longer considered a single disease, but it is classified into at least four different molecular subtypes, based on the immunohistochemical classification: Luminal A-like, Luminal B-like, HER2 positive and Triple Negative. Nowadays it is known that not only the stage of diagnosis, but also the biology of the disease influences the risk of recurrence and death. Furthermore, a growing number of trials show that different biological subtypes differ in terms of time to relapse and disease pattern of metastatic spread (in particular, site of first relapse). These observations lead to the hypothesis that different types and different frequencies of follow-up strategies should vary depending on the biology of breast cancer. Furthermore, with improved management and the availability of new effective treatments, patients with oligometastatic disease treated with an aggressive multidisciplinary approach may be amenable to curative treatment. Based on this hypothesis, an early diagnosis of metastatic disease could lead to the identification of patients with low disease burden who can still be treated with curative intent. DWB-MRI is emerging as a promising tool for the detection and therapy monitoring of metastases in different tumor types and could be an important tool for the early detection of breast cancer metastases.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWB-MRI | Experimental | Surveillance with diffusion whole body MRI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion whole body MRI | Diagnostic Test | Diffusion whole body MRI protocol, consisting of sagittal T1-weighted and T2-weighted sequences on the whole spine, axial T1 weighted, T2-weighted and diffusion-weighted images from head to mid-thigh, performed on a 1.5 T scanner. |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | Number of alive patients at 5 years (considering deaths from any cause) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival of patients underwent local treatment | Number of patients undergoing local treatment (surgery or other localized technique) who are alive at 5 years (considering deaths from any cause) | 5 years |
| Breast cancer specific survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica Iorfida, MD | Contact | +390257489970 | monica.iorfida@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Monica Iorfida, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | 20141 | Italy |
Not provided
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Number of alive patients at 5 years (considering only deaths related to breast cancer)
| 5 years |
| Safety of local treatment | Number of serious adverse event related to local treatment received | 48 months |
| Anxiety assessment | Collection of Hamilton Anxiety Rating Scale questionnaire (minimum value: 0, maximum value: 4 - higher scores mean a worse outcome) | 48 months |
| Health state assessment | Collection of 12-Item Short Form Survey (SF-12) questionnaire (minimum value: 0, maximum value: 6 - higher scores mean a better outcome) | 48 months |
| Ability to Cope With Trauma assessment | Collection of Perceived Ability to Cope With Trauma (PACT) questionnaire (minimum value: 0, maximum value: 7 - higher scores mean a better outcome) | 48 months |
| Personality assessment | Collection of Big Five Personality Inventory (BFI-10) questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a greater agreement with the statement) | 48 months |
| Acceptability and perception of DWB-MRI | Collection of Acceptance Questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a worse outcome) | 48 months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |