Biomechanics of Metastatic Defects in Bone

The Purpose of This Study is to Monitor Fracture Risk Associated With Bone Tumors in Cancer Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer Bone; Bone Tumors

Detailed Description

If a patient agrees to participate in this study, we will ask the patient to complete two written, self-administered questionnaires. The questionnaires will take about fifteen minutes to complete and contain questions about the patient's general health as well as questions specific to the site of the bone tumor. The patient will be asked to complete the first questionnaire upon enrollment in the study, and the second when participation in the study is concluded. The patient will be asked to complete and return the questionnaire to the project coordinator at this time. If for any reason the patient is unable to complete the questionnaire at this time, he/she will be asked to return it to the project coordinator within two weeks using a stamped, pre-addressed envelope, which will be provided.

The treating physician has ordered both an X-ray picture and a three-dimensional CT scan image of the involved bone plus the contralateral limb (lower limbs). He/she will be provided with a standard report from the radiologist describing the appearance of the bone tumor and the bone itself which the treating physician will use to determine the course of treatment he/she deems appropriate. We will perform a special analysis of the CT images that will allow us to estimate the strength of the bone with the tumor. Based on this engineering analysis of the strength of the bone, the treating physician may alter the prescribed treatment to decrease the risk that bone will fracture. If the patient does not have a fracture within the follow-up period (four months), he/she will undergo a second CT scan to determine the response of the tumor to treatment and changes in the strength of the bone. If the patient does have a fracture within the follow-up period, he/she will undergo a second CT scan to determine the integrity of the remaining bone to help your physician plan the next course of action. We will use the second CT scan to estimate how weak the bone was just prior to fracture. In either case, the patient's participation in this study will be concluded after the second CT scan.

Patient participation in the study will last four months. If the patient has a fracture before four months, his/her participation will end at that time.

The investigator and/or the treating physician may decide to take the patient off this study if

1. patient refuses or is unable to complete study procedures;
2. patient develops weakness or numbness in his/her limbs due to your disease;
3. patient's bone fractures due to significant trauma (e.g., traffic accident, fall from height);
4. a different bone fractures, limiting patient's ability to put pressure on the bone of interest; or
5. patient relocate.

The patient can end his/her participation at any time. The patient's decision to withdraw from the study will not affect in any way his/her medical care and/or benefits. If the patient decides to end his/her participation in the study, we encourage him/her to discuss the decision the treating physician.

STUDY LOCATION Privacy Patients will be approached by treating physicians at clinic and privately (in the examination room), where they can privately describe the study, answer any questions the patient might have and potentially enroll the patient in the study. Patient privacy and confidentiality will be strictly observed during all steps of recruitment, reporting of data and follow up conversations.

Physical Setting

All patient related activity will be conducted in the hospital as the patient undergoes treatment. CT data analysis will be performed at the Center for advanced Orthopaedic Studies at BIDMC.

DATA SECURITY All data will be kept behind BIDMC firewall at an access controlled computer designated for this study only. Additionally, the patient data will be anonymized and a number will be assigned to protect the patient identity, therefore those conducting analysis on the CT data will have no access to patient identifiable information.

• Study Type: Observational
• Enrollment (Estimated): 245

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Department of Orthopaedic Surgery, McGill University Health Centre
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Alvin and Lois Lapidus Cancer Center, Sinai Hospital of Baltimore, Inc
  • Massachusetts
    • Boston, Massachusetts, United States
      • Department of Orthopaedic Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Department of Orthopaedic Surgery, University of Minnesota Medical Center
  • New York
    • Syracuse, New York, United States, 13057
      • Department of Orthopedic Surgery, Upstate Medical University
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Department of Orthopaedic Surgery, Rhode Island Hospital
  • Texas
    • Houston, Texas, United States
      • Section of Orthopaedic Oncology, University of Texas M. D. Anderson Cancer Center
  • West Virginia
    • Huntington, West Virginia, United States
      • Edwards Comprehensive Cancer Center, Marshall University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• 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.

Description

Inclusion Criteria:

Patient with metastatic cancer bone lesions

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture Risk Assessment in Patients with Skeletal Metastasis	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.	0-4 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Fracture Risk Assessment in Patients with Skeletal Metastasis (Following-up with Changes)	4-12 Months

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Ara Nazarian, PhD, anazaria@bidmc.harvard.edu

Publications and helpful links

Helpful Links

• Guide website to join this study

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimated): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Bone Neoplasms
• Other Study ID Numbers: 2008P000285