NCT05744518

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

January 28, 2023

Last Update Submit

February 24, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Image Quality

    6 Months Post Surgery

Interventions

Response monitoringOTHER

Other: Response monitoring (no intervention)

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Female;
  • Age 18 years or older;
  • Diagnosis of invasive breast cancer by ultrasound guided biopsy;
  • \. Planed for receiving neoadjuvant chemotherapy (NAC) 4. Planned definitive breast surgery following completion of NAC.

You may not qualify if:

  • Stage IV breast cancer;
  • Previous ipsilateral breast cancer;
  • Previous treatment (chemotherapy or radiation) to involved breast;
  • Medically unstable;
  • Pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200232, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yajia Gu, MD

CONTACT

+86186168767637583724@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Radiology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 27, 2023

Study Start

January 3, 2022

Primary Completion

January 3, 2024

Study Completion

July 1, 2024

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations

CN(1)