Clinical Trial: Biomechanics of Metastatic Defects in Bone

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

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.


Detailed Summary:

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.
Sponsor: Beth Israel Deaconess Medical Center

Current Primary Outcome: 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.


Original Primary Outcome: Fracture Risk Assessment in Patients with Skeletal Metastasis [ Time Frame: First measurment is right after patient's agreement and consent to join the study. Second follow up is 4 months after the first visit. Third measurment is one year after the frist visit. ]

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.


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

Original Secondary Outcome: To evaluate whether medical and/or surgical interventions for individual patients based on standard clinical and radiographic fracture risk guidelines are changed by CT-based fracture risk assessments [ Time Frame: First measurment is right after patient's agreement and consent to join the study. Second follow up is 4 months after the first visit. Third measurment is one year after the frist visit. ]

If the treatment proposed for an individual patient with a skeletal metastasis based on standard clinical and radiographic fracture risk criteria is changed by the CT-based fracture risk assessment, the orthopaedic oncologist will select a treatment (chemotherapy ± radiation, surgical stabilization, intercalary allograft and/or prosthetic replacement) based on the fracture risk assessment using standard clinical and radiographic guidelines and then again after the CT-based rigidity analysis. Chi squared analysis will be conducted to determine the concordance between the treatment plans developed using the two fracture risk assessments. We intend to identify when the CT-based rigidity analysis will be the most useful clinically. Treatment plans will be similar in cases where there is either marked bony destruction or minimal bone involvement. It is likely that the CT-based rigidity analysis will be most valuable in cases where bone destruction is moderate or osteoporosis is coexistent.


Information By: Beth Israel Deaconess Medical Center

Dates:
Date Received: March 31, 2014
Date Started: January 2009
Date Completion: December 2018
Last Updated: March 9, 2017
Last Verified: March 2017