Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02109952 |
| Other study ID # |
2008P000285 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2009 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Beth Israel Deaconess Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
