Radiation Effects on Bone

NCT03134742 | Unknown

• 1 other identifier: 1019460
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Soft Tissue Sarcoma Adult

Keywords

soft tissue sarcoma extremities

Outcome Measures

Primary Outcomes (1)

• Determine whether subjects undergoing radiotherapy for soft tissue sarcoma exhibit abscopal bone loss

  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)

  12 months post radiation

Secondary Outcomes (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

  12 months post radiation

Study Arms (4)

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

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

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

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

Interventions

Control Group OTHER

No interventions this is the control group-no additional scans

Control Group

CT Scan DIAGNOSTIC_TEST

CT Scan of affected and contralateral limb

CT Scan only

DEXA Scans DIAGNOSTIC_TEST

DEXA Scan of affected and contralateral limb

DEXA Scans only

CT and DEXA Scans DIAGNOSTIC_TEST

CT Scan and DEXA Scan of affected and contralateral limb

CT and DEXA Scans

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Interventions

Control Groups; Tomography, X-Ray Computed; Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Densitometry; Photometry; Chemistry Techniques, Analytical

Study Officials

• Timothy Damron, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David G. Murray Professor of Orthopedic Surgery

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: March 13, 2017
• Primary Completion: April 13, 2025
• Study Completion: April 13, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)