NCT03709186

Brief Summary

The primary aim of the study is to identify radiomic features as biomarkers of metastatic progression following primary therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

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

October 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

April 11, 2023

Status Verified

October 1, 2019

Enrollment Period

1.9 years

First QC Date

October 12, 2018

Last Update Submit

April 10, 2023

Conditions

Invasive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Pathologic complete response (pCR)

    Evaluating the degree of absence of residual cancer cells

    Up to 60 months

Secondary Outcomes (3)

  • Time to distant breast cancer recurrence (months)

    Up to 60 months

  • Time to distant metastasis

    Up to 60 months

  • Time to death

    Up to 60 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will enrol women and men with a pathologically-confirmed diagnosis of invasive breast cancer that is stage I-III according to the AJCC v7 criteria.

You may qualify if:

  • Subjects must give appropriate written informed consent prior to participation in the study;
  • Subjects must be able and willing to comply with the safety procedures during the scanning period;
  • Subjects must be men and women age 18+
  • Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-).
  • Stage I-III disease according to the AJCC v7 criteria.
  • Patients with sufficient renal function (creatinine clearance, i.e., \>=30 mL/min/1.73 m2).
  • Primary treatments can include neoadjuvant chemotherapy or surgery

You may not qualify if:

  • \. Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. Silicone/saline implants) involving either breast, exclusive of the lesion at issue.
  • \. Allergies to any contrast agent administered to this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Study Officials

  • William T. Tran, MRT(T), PhD

    Radiation Therapist Clinician Scientist

    PRINCIPAL INVESTIGATOR

  • Colleen Bailey, PhD

    Sunnybrook Research Institute

    PRINCIPAL INVESTIGATOR

  • Angus Lau, PhD

    Sunnybrook Research Institute

    PRINCIPAL INVESTIGATOR

  • Kasia Jerzak, MD, MSc

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Therapist Clinician Scientist

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 17, 2018

Study Start

October 1, 2018

Primary Completion

September 1, 2020

Study Completion

January 1, 2021

Last Updated

April 11, 2023

Record last verified: 2019-10

Locations

CA(1)