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

NCT ID: NCT05744518

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Response monitoring
Description: Other: Response monitoring (no intervention)

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200232
Country: China

Status: Recruiting

Contact:
Last name: Yajia Gu, MD

Phone: +8621-64175590
Email: 7583724@qq.com

Start date: January 3, 2022

Completion date: July 1, 2024

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05744518

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