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

NCT ID: NCT05744518

Last Updated: 2023-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-03

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Response monitoring

Other: Response monitoring (no intervention)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Yajia Gu, MD

Director, Head of Radiology, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yajia Gu, MD

Role: CONTACT

+8618616876763

Facility Contacts

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Yajia Gu, MD

Role: primary

+8621-64175590

Other Identifiers

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MR-01

Identifier Type: -

Identifier Source: org_study_id

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