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临床试验/NCT02109952
NCT02109952进行中(未招募)不适用

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

Beth Israel Deaconess Medical Center8 个研究点 分布在 2 个国家目标入组 245 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
245
试验地点
8
主要终点
Fracture Risk Assessment in Patients with Skeletal Metastasis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with metastatic cancer bone lesions

排除标准

  • 未提供

结局指标

主要结局

Fracture Risk Assessment in Patients with Skeletal Metastasis

时间窗: 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.

次要结局

  • Fracture Risk Assessment in Patients with Skeletal Metastasis (Following-up with Changes)(4-12 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ara Nazarian

Assistant Professor of Orthopedic Surgery

Beth Israel Deaconess Medical Center

研究点 (8)

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