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Radiation Effects on Bone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03134742
Recruitment Status : Enrolling by invitation
First Posted : May 1, 2017
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Timothy Damron, M.D., State University of New York - Upstate Medical University

Brief Summary:
Post-radiotherapy fragility fractures (caused by weakened bones) are an occasional complication of orthopedic oncology of soft tissue sarcoma patients. Treatment for impending fracture due to radiotherapy does exist in the form of operative stabilization, to prevent the bone from breaking. Without the ability to predict those patients at a higher risk for fracture, indications for treatment are difficult to determine. This study is to determine if there is a correlation between patients undergoing radiotherapy for soft tissue sarcoma and loss of bone density. The study wll evaluate bone loss for short and long term fracture prediction using dual-energy xray, absorptiometry (DEXA [DXA]) and computerized tomography scans (CT Scans)

Condition or disease Intervention/treatment
Soft Tissue Sarcoma Adult Other: Control Group Diagnostic Test: CT Scan Diagnostic Test: DEXA Scans Diagnostic Test: CT and DEXA Scans

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Abscopal Radiation Effects on Regional and Distant Bone
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : April 13, 2025
Estimated Study Completion Date : April 13, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control Group
Subjects will not have any additional scans only those that are standard of care. Their data will be used for comparison
Other: Control Group
No interventions this is the control group-no additional scans

CT Scan only
Three CT Scans will be done of the affected extremity as well as the contralateral extremity at Baseline (pre-radiotherapy), and 6 months and 1 year post-radiotherapy treatment.
Diagnostic Test: CT Scan
CT Scan of affected and contralateral limb

DEXA Scans only
Three DEXA Scans will be done of the affected extremity as well as the contralateral extremity at Baseline (pre-radiotherapy), and 6 months and 1 year post-radiotherapy treatment
Diagnostic Test: DEXA Scans
DEXA Scan of affected and contralateral limb

CT and DEXA Scans
Three CT Scans and three DEXA Scans will be done of the affected extremity as well as the contralateral extremity at Baseline (pre-radiotherapy), and 6 months and 1 year post-radiotherapy treatment
Diagnostic Test: CT and DEXA Scans
CT Scan and DEXA Scan of affected and contralateral limb




Primary Outcome Measures :
  1. Determine whether subjects undergoing radiotherapy for soft tissue sarcoma exhibit abscopal bone loss [ Time Frame: 12 months post radiation ]
    CT Scans combined with calibration phantoms will be used to quantify bone density, when compare pre- and post-radiotherapy at the site of irradiation and at distant sites (contralateral limb)


Secondary Outcome Measures :
  1. Comparing effectiveness of utilization of CT vs DEXA as a tool to evaluate bone loss in short term with potential for long term fracture prediction [ Time Frame: 12 months post radiation ]
    DEXA Scans will be used to evaluate the potential abscopal bone loss by assessing changes in bone mineral density as measured by DEXA, when compared pre- and post-radiotherapy at the site of irradiation and at distant sites (contralateral limb)



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects between the ages of 18 and 89 years of age, who have been diagnosed with soft tissue sarcoma of an extremity, who have not had radiotherapy treatment, or been diagnosed with metastatic carcinoma, atypical lipomatous tumors or low grade soft tissue sarcomas.
Criteria

Inclusion Criteria:

  • Patients of Dr. Damron's being treated for soft tissue sarcoma of an extremity, who will undergone radiotherapy, and will follow with Dr. Damron for routine oncology surveillance with routine CT scans of the chest at minimum.
  • Must be at least 18 years of age and no older than 89 years of age.

Exclusion Criteria:

  • Patients who are treated with radiotherapy but who do not have soft tissue sarcoma, such as those with metastatic carcinoma,
  • Patients who have soft tissue sarcoma who will not receive adjuvant radiotherapy, such as those with atypical lipomatous tumors or other low grade soft tissue sarcomas
  • Patients who will not be obtaining their follow up CT studies at Upstate Bone and Joint Center-since the calibration phantom needs to be located in one central location.
  • Incarcerated patients
  • Patients younger than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134742


Locations
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United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
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Principal Investigator: Timothy Damron, MD State University of New York - Upstate Medical University
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Responsible Party: Timothy Damron, M.D., David G. Murray Professor of Orthopedic Surgery, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT03134742    
Other Study ID Numbers: 1019460
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Timothy Damron, M.D., State University of New York - Upstate Medical University:
soft tissue sarcoma extremities
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms