Monitoring Response to Neoadjuvant Chemotherapy in Breast Cancer Using Ultrafast DCE-MRI

Breast Cancer Clinical Trial

Official title:

Monitoring Response to Neoadjuvant Chemotherapy in Breast Cancer Using Ultrafast Dynamic Contrasted-Enhancement Magnetic Resonance Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744518
• Other study ID #: MR-01
• Status: Recruiting
• Start date: January 3, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2023
• Source: Fudan University
• Contact: Yajia Gu, MD
• Phone: +8618616876763
• Email: 7583724[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Response monitoring
Other: Response monitoring (no intervention)

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

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