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.
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
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.
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.
|Clinical Study Identifier||NCT02109952|
|Sponsor||Beth Israel Deaconess Medical Center|
|Last Modified on||8 November 2020|
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.Learn more
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.Learn more
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