NCT01684735

Brief Summary

Evaluation of the response to chemotherapy in breast cancer patients by the use of Diffusion-weighted magnetic resonance imaging of the breast before the start of chemotherapy, after one and 3 cycles of therapy and at the end of the therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 31, 2023

Status Verified

September 1, 2012

Enrollment Period

2.8 years

First QC Date

May 14, 2012

Last Update Submit

January 27, 2023

Conditions

Breast Cancer

Keywords

diffusion-weighted magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Response to chemotherapy

    outcome is the results of pathology after chemotherapy and surgery. Data will be collected for a period of 1 year.

    1 year

Study Arms (1)

women with BRCA and chemotherapy

women recently diagnosed with breast cancer and start with neo-adjuvant chemotherapy (6 cycles) before surgery/therapy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women diagnosed with breast cancer and treated with neo-adjuvant chemotherapy

You may qualify if:

  • core biopsy with diagnosis of breast cancer
  • start of neo-adjuvant chemotherapy

You may not qualify if:

  • magnetic resonance imaging incompatibility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 300, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chantal Van Ongeval, MD, Phd

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

September 13, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 31, 2023

Record last verified: 2012-09

Locations

BE(1)