Endoprosthesis Metal Toxicity Study

NCT04755140 | Completed

• 3 other identifiers: 20-008408R01AG060920R01HL147155-02
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to investigate whether patients who previously had endoprosthesis surgery experience memory, thinking, or heart problems. It will also help determine how often these problems occur.

Conditions

Bone Tumor; Cancer of Bone; Heart Diseases; Cognitive Impairment; Cognitive Decline; Chemotherapy Effect; Memory Problem

Keywords

Endoprosthesis; Metallosis; Toxicity

Outcome Measures

Primary Outcomes (6)

• Echo - Left Ventricular Ejection Fraction

  The echocardiogram will measure changes in LV ejection fraction as a percent.

  Echo's will be taken at baseline, 1 year, and 2 years

• Echo - Left Ventricular Mass

  The echocardiogram will measure changes in LV Mass in grams.

  Echo's will be taken at baseline, 1 year, and 2 years

• Echo - Heart Hypertrophy

  The echocardiogram will measure changes in concentric or eccentric hypertrophy in centimeters.

  Echo's will be taken at baseline, 1 year, and 2 years

• Cobalt Metal Levels

  The change in cobalt blood ion levels will be measured in ng/mL.

  Cobalt level will be measured at baseline, 1 year, and 2 years

• Chromium Metal Levels

  The change in chromium blood ion levels will be measured in ng/mL.

  Chromium level will be measured at baseline, 1 year, and 2 years

• Titanium Metal Levels

  The change in titanium blood ion levels will be measured in ng/mL.

  Titanium level will be measured at baseline, 1 year, and 2 years

Secondary Outcomes (2)

• Psychometrist Testing - Intelligence Score

  Testing will occur at baseline, 1 year, and 2 years.

• Psychometrist Testing - Memory Score

  Testing will occur at baseline, 1 year, and 2 years.

Study Arms (1)

Endoprosthesis

Patients with a endoprosthesis

Behavioral: Questionnaires; Behavioral: Interviews; Diagnostic Test: Blood Test; Diagnostic Test: Echocardiogram

Interventions

Questionnaires BEHAVIORAL

The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.

Endoprosthesis

Interviews BEHAVIORAL

Cognition and memory interviews will take place with the patient.

Endoprosthesis

Blood Test DIAGNOSTIC_TEST

Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.

Endoprosthesis

Echocardiogram DIAGNOSTIC_TEST

Each echocardiogram takes about 3 hours and 30 minutes. This test uses sound waves to look at your heart. The person doing the test will press on your chest with a machine to obtain the pictures. The pressure may be uncomfortable. The echocardiogram will involve an image enhancement agent infusion to obtain better images.

Endoprosthesis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 patients to complete cardiology part of the study (questionnaires, blood test, echocardiogram). 150 patients to complete cognitive part of the study (questionnaires, interviews, blood test). Patient groups may overlap.

You may qualify if:

• Patient has an endoprosthesis after extremity malignancy

You may not qualify if:

• Current fracture or infection around the endoprosthesis
• Patient is pregnant

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected from patients and ran through a CyTOF procedure to identify immune cells within the samples.

MeSH Terms

Conditions

Bone Neoplasms; Heart Diseases; Cognitive Dysfunction; Memory Disorders

Interventions

Surveys and Questionnaires; Interviews as Topic; Hematologic Tests; Echocardiography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Matthew Houdek, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 15, 2021
• Study Start: March 19, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-05

Locations

US (1)