NCT01428739

Brief Summary

Correlation between MRS and Tumor Response Therapy in Breast Cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable breast-cancer

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

December 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2010

Completed
11 months until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 25, 2017

Status Verified

October 1, 2014

Enrollment Period

6.8 years

First QC Date

October 21, 2010

Last Update Submit

January 23, 2017

Conditions

Breast Cancer

Keywords

cancerMRSTreatment response

Outcome Measures

Primary Outcomes (1)

  • MRS Correlation with Treatment Response

    measuring choline, water and fat levels by proton magnetic resonance spectroscopy in breast tumors in response to treatment

    Up to One Year

Secondary Outcomes (1)

  • Correlation with Tumor Stage

    Up to One year

Interventions

MRSDEVICE

Procedure

Also known as: Philips 3 Tesla MRI Scanner

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosed Breast cancer
  • Patient is 18 years or older
  • Karnofsky performance score \> 70
  • No previously irradiated or recurrent breast cancer
  • No contraindication to MRS/MRI
  • Signed informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nadeem Pervez, MBBS, FFRRCSI, FRCPC

    Cross Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2010

First Posted

September 5, 2011

Study Start

December 1, 2007

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 25, 2017

Record last verified: 2014-10

Locations

CA(1)