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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