NCT00592462

Brief Summary

The objective of this pilot study is to develop and evaluate a whole body MRI technique for detecting cancer metastases. The whole body MRI will include T1-weighted and T2-weighted phase-sensitive MR imaging as well as diffusion weighted imaging of the whole body in multiple patient table stations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 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

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

8 years

First QC Date

January 2, 2008

Last Update Submit

October 26, 2016

Conditions

Breast Cancer

Keywords

Breast CancerWhole Body MRIMagnetic Resonance ImagingMetastases

Outcome Measures

Primary Outcomes (1)

  • Develop and evaluate a whole body MRI technique for detecting cancer metastases.

    3 Years

Study Arms (1)

Whole Body MRI

Procedure: Whole Body MRI

Interventions

Whole Body MRIPROCEDURE

The whole body MRI will include T1-weighted and T2-weighted phase-sensitive MR imaging as well as diffusion weighted imaging of the whole body in multiple patient table stations.

Whole Body MRI

Eligibility Criteria

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

Breast cancer patients with a high suspicion or confirmed bone metastases.

You may qualify if:

  • Breast cancer patients with high suspicion or confirmed bone metastases.
  • Patient who have undergone a clinically indicated skeletal scintigraphy within two weeks of the MRI exam.
  • Patients who have signed their informed consent form to undergo the study.

You may not qualify if:

  • \) Contraindication to conventional MR imaging (e.g. metal implants, pace maker, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jingfei Ma, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 14, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

US(1)