NCT00420433

Brief Summary

Primary Objectives:

  • To estimate and compare the sensitivity and specificity of computed tomography (CT), plain radiography (XR), and skeletal scintigraphy (SS) with each other for the assessment of response of bone metastasis in patients with breast cancer.
  • To estimate and compare the sensitivity and specificity of M. D. Anderson (MDACC) bone metastasis criteria with that of current criteria (UICC, WHO) in breast cancer patients for the assessment of the behavior of osseous metastasis in breast cancer patients. Secondary Objective:
  • To evaluate the progression free survival (PFS) and overall survival (OS) of each response group (CR, PR, SD, PD) assessed by imaging and response criteria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2004

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

September 1, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

February 19, 2016

Status Verified

May 1, 2012

Enrollment Period

4.1 years

First QC Date

January 9, 2007

Last Update Submit

February 17, 2016

Conditions

Breast CancerBone Metastases

Keywords

Breast CancerBone MetastasesRadiographyX-RayComputed TomographyCT ScanSkeletal Scintigraphy

Outcome Measures

Primary Outcomes (1)

  • To compare different imaging techniques in measuring the response of bone disease to treatment.

    5 Years

Secondary Outcomes (2)

  • To compare different evaluation techniques (evaluation criteria) in reading the images.

    5 Years

  • To study the change in the response of blood serum markers and the reliability of biochemical markers.

    5 Years

Study Arms (1)

1

Patients with breast cancer that has spread to the bones.

Procedure: Skeletal ScintigraphyProcedure: RadiographyProcedure: CT Scan

Interventions

Skeletal ScintigraphyPROCEDURE

Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.

1
RadiographyPROCEDURE

Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.

Also known as: X-Ray
1
CT ScanPROCEDURE

CT scan will include your chest, abdomen, and pelvis. Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.

Also known as: Computed Tomography
1

Eligibility Criteria

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

Study participants with breast cancer that has spread to the bones.

You may qualify if:

  • Newly diagnosed bone (from calvarium to pelvis include ribs and sternum) and nonosseous (it should be measurable by CT) metastasis or primary breast tumor (with a confirmation of no surgical treatment for 12 months) from breast cancer. If the bone metastasis is not confirmed by imaging, bone biopsy is needed. Please see diagnostic flow sheet. (APPENDIX B)
  • Zubrod performance status 2 or less. (APPENDIX A)
  • Patient must receive systemic treatment (e.g., chemotherapy, hormonal therapy) for this newly diagnosed metastatic disease. (Additional bisphosphonate treatment will be acceptable.)
  • Patients must sign an informed consent document indicating awareness that this study is not focusing on the verification of treatment agents but on verification of modalities to assess bone tumor response, in keeping with institutional policy.

You may not qualify if:

  • Patients who have less than 3 months interval from completion of treatment (chemotherapy and/or radiation therapy) for primary breast cancer.
  • Patients who have the history of radiation therapy for bone disease.
  • History or presence of brain/leptomeningeal metastasis.
  • History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Naoto Ueno, MD, 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 9, 2007

First Posted

January 11, 2007

Study Start

September 1, 2004

Primary Completion

October 1, 2008

Study Completion

May 1, 2012

Last Updated

February 19, 2016

Record last verified: 2012-05

Locations

US(1)