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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Response monitoring

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Yajia Gu, MD; Phone Number: +8618616876763; Email: 7583724@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200232
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Yajia Gu, MD; Phone Number: +8621-64175590; Email: 7583724@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Eligible female breast cancer patients receiving NAC at Fudan University Shanghai Cancer Center

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Anticipated): January 3, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: MR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No