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Trial record 2 of 33 for:    Radiology | Recruiting, Not yet recruiting, Active, not recruiting Studies | Bone Cancer

Biomechanics of Metastatic Defects in Bone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02109952
Recruitment Status : Recruiting
First Posted : April 10, 2014
Last Update Posted : June 11, 2018
Information provided by (Responsible Party):
Ara Nazarian, Beth Israel Deaconess Medical Center

Brief Summary:

The purpose of this study is to monitor fracture risk associated with bone tumors in cancer patients.

Previous studies from our lab have suggested that it is possible to compute the mechanical strength of bones with tumors using computed tomography (CT) scans, which are like three-dimensional X-ray pictures of the affected bones.

The next step in determining the usefulness of this type of strength analysis is to see if we can accurately predict who is at risk for bone fracture and which patients are at high risk of fractures.

This non-invasive analysis may help physicians determine the best treatment to reduce the risk of an impending bone fracture in the future.

Condition or disease
Cancer Bone Bone Tumors

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 245 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Purpose of This Study is to Monitor Fracture Risk Associated With Bone Tumors in Cancer Patients
Study Start Date : January 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Fracture Risk Assessment in Patients with Skeletal Metastasis [ Time Frame: 0-4 Months ]
    Based on past studies, metastatic lesion in cancer bone alters both the material and geometric properties of the bone while rigidity, the structural property, integrates both two properties in bone. For a cancerous bone, the axial (EA), bending (EI), and torsional (GJ) rigidity determine the capacity of the bone to resist axial, bending and twisting loads respectively. Because the weakest segment of the bone dictates the load capacity of the entire bone, we have developed algorithms to calculate the minimal rigidity of a bone with an osteolytic lesion using serial, trans-axial, computed tomography (CT) images through the affected bone to measure both the bone tissue mineral density and cross-sectional geometry. If the ratio of EA, EI or GI in compare with the normal bone's EA, EI, or GI was 65% or less, pathological fracture will be predicted. This non-invasive analysis may help physicians determine the best treatment to reduce the risk of an impending bone fracture in the future.

Secondary Outcome Measures :
  1. Fracture Risk Assessment in Patients with Skeletal Metastasis (Following-up with Changes) [ Time Frame: 4-12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
When a patient presents to the orthopaedic oncologist with lower appendicular skeletal skeletal metastasis, as per standard clinical practice biplanar radiographs and CT scans of the involved bone(s) plus the contralateral limb will be obtained. Informed consent will be obtained for CT scan with the contralateral limb (Both limbs are in the gantry and are imaged together-this is not an additional step, as this is how patients are scanned for general care of lesions in the lower limbs) to provide a patient specific internal control and calcium hydroxyapatite phantom for standardizing bone density estimates. Post-processing of the image data will be conducted by the Orthopaedic Biomechanics Lab at BIDMC to calculate fracture risk associated with the bone lesion.

Inclusion Criteria:

Patient with metastatic cancer bone lesions

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02109952

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Contact: Ara Nazarian, PhD
Contact: Diana Cepeda 617-667-1843

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United States, Maryland
Alvin and Lois Lapidus Cancer Center, Sinai Hospital of Baltimore, Inc Recruiting
Baltimore, Maryland, United States, 21215
Contact: Melissa A Loomis    410-601-9083   
Principal Investigator: Janet Conway, MD         
United States, Massachusetts
Department of Orthopaedic Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School Active, not recruiting
Boston, Massachusetts, United States
United States, Minnesota
Department of Orthopaedic Surgery, University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States
Contact: Edward Cheng, MD   
Principal Investigator: Edward Cheng, MD         
United States, New York
Department of Orthopedic Surgery, Upstate Medical University Recruiting
Syracuse, New York, United States, 13057
Contact: Tina Craig   
Principal Investigator: Timothy Damron,, MD         
United States, Rhode Island
Department of Orthopaedic Surgery, Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02905
Contact: Richard Terek, MD   
Principal Investigator: Richard Terek, MD         
United States, Texas
Section of Orthopaedic Oncology, University of Texas M. D. Anderson Cancer Center Active, not recruiting
Houston, Texas, United States
United States, West Virginia
Edwards Comprehensive Cancer Center, Marshall University Recruiting
Huntington, West Virginia, United States
Contact: Felix Cheung, MD   
Principal Investigator: Felix H Cheung, MD         
Canada, Quebec
Department of Orthopaedic Surgery, McGill University Health Centre Recruiting
Montreal, Quebec, Canada
Contact: Robert Turcotte, MD   
Principal Investigator: Robert Turcotte         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Principal Investigator: Ara Nazarian, PhD

Additional Information:
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Responsible Party: Ara Nazarian, Assistant Professor of Orthopedic Surgery, Beth Israel Deaconess Medical Center Identifier: NCT02109952     History of Changes
Other Study ID Numbers: 2008P000285
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases