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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05744518
Enrollment
80
Registered
2023-02-27
Start date
2022-01-03
Completion date
2024-07-01
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

Interventions

OTHERResponse monitoring

Other: Response monitoring (no intervention)

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Complete Pathologic Response (pCR)6 Months Post SurgeryThe 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.

Secondary

MeasureTime frameDescription
Image Quality6 Months Post SurgeryThe 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

Countries

China

Contacts

Primary ContactYajia Gu, MD
7583724@qq.com+8618616876763

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026