Breast Cancer Clinical Trial
Official title:
Monitoring Response to Neoadjuvant Chemotherapy in Breast Cancer Using Ultrafast Dynamic Contrasted-Enhancement Magnetic Resonance Imaging
NCT number | NCT05744518 |
Other study ID # | MR-01 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 3, 2022 |
Est. completion date | July 1, 2024 |
Verified date | February 2023 |
Source | Fudan University |
Contact | Yajia Gu, MD |
Phone | +8618616876763 |
7583724[@]qq.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study will assess whether changes in kinetic parameters of tumor and peritumoral vasculature using ultrafast dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) during neoadjuvant chemotherapy (NAC) are predictive of pathologic complete response (pCR) in patients with breast cancer appropriate for NAC. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | July 1, 2024 |
Est. primary completion date | January 3, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Female; 2. Age 18 years or older; 3. Diagnosis of invasive breast cancer by ultrasound guided biopsy; 3. Planed for receiving neoadjuvant chemotherapy (NAC) 4. Planned definitive breast surgery following completion of NAC. Exclusion Criteria: 1. Stage IV breast cancer; 2. Previous ipsilateral breast cancer; 3. Previous treatment (chemotherapy or radiation) to involved breast; 4. Medically unstable; 5. Pregnant or nursing. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete Pathologic Response (pCR) | The primary aim of this feasibility study is to determine whether ultrafast dynamic contrasted-enhancement magnetic resonance imaging (DCE-MRI) at baseline prior to first cycle neoadjuvant chemotherapy (NAC), after first cycle NAC, and prior to second cycle NAC can accurately predict complete pathologic response (pCR) in women with breast cancer. | 6 Months Post Surgery | |
Secondary | Image Quality | The second aim of this feasibility study is to determine whether ultrafast dynamic contrasted-enhancement magnetic resonance imaging (DCE-MRI) can provide the relatively high resolution, high contrast-noise ration, and good contrast with ultrafast DCE-MRI | 6 Months Post Surgery |
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