NCT02649699

Brief Summary

The purpose of this pilot study is to test new magnetic resonance imaging (MRI) acquisition and processing techniques on primary brain tumor patients. The objectives are to improve image-guided radiation therapy (IGRT) planning (first part of the study) and treatment monitoring (second part).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

December 31, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 14, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

5.2 years

First QC Date

December 31, 2015

Last Update Submit

January 29, 2024

Conditions

Brain Tumors

Keywords

Primary Brain Cancer

Outcome Measures

Primary Outcomes (1)

  • Comparisons of radiation treatment plans by means of tumor control probabilities calculated from dose-volume histograms

    12 months

Study Arms (1)

Additional 3D MRI scans

OTHER

Participating patients will receive additional 3D MRI scans during pre and post RT planning for their primary brain tumors.

Other: 3D MRI Scans

Interventions

3D MRI ScansOTHER

Patients will receive additional MRI scans before commencing their radiation treatment, at 3-4 months, 6 months and 12 months post RT as well as at recurrence or suspected recurrence.

Additional 3D MRI scans

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age.
  • Competent to sign informed consent.
  • Diagnosed with primary tumor of the brain.
  • Undergoing IGRT.
  • Willing to participate in initial and follow up scan(s).
  • Can lie supine in the MRI scanner for a period of about 45 minutes.
  • Has signed informed consent.

You may not qualify if:

  • Pregnancy.
  • Contraindications to MRI (e.g., pacemakers, magnetic implants, metal in eye, claustrophobia).
  • Has metallic implants in regions of interest (dental braces are okay).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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

December 31, 2015

First Posted

January 7, 2016

Study Start

April 14, 2016

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)