Neoplasms

Musculoskeletal Diseases

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Rare Diseases

Bone Neoplasms

Bone Diseases

Oculocerebral Syndrome With Hypopigmentation

All Drugs and Chemicals

Micronutrients

Technetium Tc 99m Medronate

Molybdenum

Sodium Pertechnetate Tc 99m

Radiopharmaceuticals

Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo. The images of the 99mTc MDP Injection-neutron-bombardment will be compared to the previous (on file) images from the 99mTc MDP Injection-fission

Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.

99mTc MDP Injection:neutron-bombardment

Sandor J Demeter, MSc MD FRCPC

A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc -MDP, is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology using the same oncologic indications as nuclear reactor sourced 99mTc, as 99mTc-MDP.

This clinical trial will be a comparison of diagnostic and imaging equivalency of 99mTc Pertechnetate intravenous injection (labeled with commercial MDP kits) produced by a non-fission sourced/solvent generator and a nuclear reactor/column sourced generator. Each oncologic participant acts as their own control to reduce error variance.

Condition Intervention Phase Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo. Drug: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo. Phase 3

Sodium Pertechnetate (99Tc) Injection Generator: 99mTc From Neutron-activation 99Mo v 99mTc From Fission 99Mo

A Cross-over Comparison of the Diagnostic Accuracy of Technetium (99mTc) Medronate Injection Prepared With 99mTc Derived From Neutron-activation Produced 99Mo Versus the Current Reference Standard of 99mTc Derived From Fission-produced 99Mo

All enrolled patients were re-imaged 3 to 28 days post a standard of care fission derived 99Mo bone scan using neutron-activation produced 99Mo as the investigational product. Per protocol dosage, time factors, injection site and imaging camera were matched. Resulting image sets (fission and neutron-activation) were analyzed visually for concordant biodistribution.

Winnipeg Regional Health Authority

University of Manitoba

Head, Nuclear Medicine

Safety population included all participants who received investigational product 99mTc MDP Injection derived from neutron-bombardment. Safety assessments: telephone interview at 14 days, chart check at 30 days.

Oncologic indication for which a bone scan would normally be indicated.

99mTc MDP Injection:fission: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.

99mTc MDP Injection:Fission

Oncologic indication for which a bone scan would normally be indicated. Participant having recently had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.

99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.

99mTc MDP Injection:Neutron-bombardment

Age, Categorical

Age, Continuous

Sex: Female, Male

Canada

Region of Enrollment

Early termination. Despite a relatively comprehensive review of the first four subject's bone imaging scans a cause of an observed altered biodistribution is not apparent. As such study recruitment will be terminated.

Dr. Sandor Demeter

No statistical analysis - insufficient study population

Each participant (4) acted as their own control to reduce variance. Paired image sets were analyzed visually for concordant biodistribution between the 99mTc Medronate Injection prepared with 99mTc derived from Neutron-activation produced 99Mo versus 99mTc Medronate Injection derived from Fission-produced 99Mo referenced as the baseline standard.

Number of Participants Analyzed for Diagnostic Efficacy of Technetium (99mTc) Medronate Injection Prepared With 99mTc Derived From Neutron-activation Produced 99Mo Imaging Sensitivity Versus 99mTc Derived From Fission-produced 99Mo Imaging Sensitivity.

Oncologic indication for which a bone scan would normally be indicated. All 4 participants initially had a bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from fission-sourced 99Mo.

3-28 days later all participants had a second bone scan using Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.

Overall Study

Heart and Blood Diseases

Behaviors and Mental Disorders

Heart Diseases

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

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

Questionnaires

Cognition and memory interviews will take place with the patient.

Interviews

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

Blood 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.

Echocardiogram

Matthew Houdek, MD

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.

At your first visit you will be asked to do the following:

1. Sign the consent document.
2. Patient Interview: An interview will be conducted by the study coordinator on the research team. They will ask your past surgical history, health history, medications, and your cognition.
3. Informant Interview: A close friend, spouse of relative of you will be interviewed about your day-day cognition.
4. Memory Interview: You will be evaluated on your memory and thinking skills three total times. One to determine baseline, and then repeated at one year and two years. You will answer questions that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.
5. Blood Draw: You will have a blood draw three times (4.2-5 tablespoons) to determine your baseline, 1 year, and 2 year research results.

6: Echocardiogram: You will be asked to have three echocardiograms. One to determine baseline, and then repeated at one year and two years.

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

Endoprosthesis Metal Toxicity Study

Evaluation and Clinical Impact of Serum and Blood Metal Ion Levels in Patients With an Endoprosthesis

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

The echocardiogram will measure changes in LV Mass in grams.

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

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

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

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

The change in participants' intelligence will be measured using the Wechsler Adult Intelligence Scale. The scale is based of scores of 50 to 150. The higher the score the better the outcome. The average outcome will be a score of 100.

The change in participants' memory will be measured using the Wechsler Adult Memory Scale. The scale is based of scores of 50 to 150. The higher the score the better the outcome. The average outcome will be a score of 100.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sodium Pertechnetate (99Tc) Injection Generator: 99mTc From Neutron-activation 99Mo v 99mTc From Fission 99Mo	NCT03002454	Cancer of Bone	99mTc MDP Injec...	18 Years -	University of Manitoba
Endoprosthesis Metal Toxicity Study	NCT04755140	Bone Tumor Cancer of Bone Heart Diseases Cognitive Impai... Cognitive Decli... Chemotherapy Ef... Memory Problem	Questionnaires Interviews Blood Test Echocardiogram	18 Years - 100 Years	Mayo Clinic
Endoprosthesis Metal Toxicity Study	NCT04755140	Bone Tumor Cancer of Bone Heart Diseases Cognitive Impai... Cognitive Decli... Chemotherapy Ef... Memory Problem	Questionnaires Interviews Blood Test Echocardiogram	18 Years - 100 Years	Mayo Clinic
Endoprosthesis Metal Toxicity Study	NCT04755140	Bone Tumor Cancer of Bone Heart Diseases Cognitive Impai... Cognitive Decli... Chemotherapy Ef... Memory Problem	Questionnaires Interviews Blood Test Echocardiogram	18 Years - 100 Years	Mayo Clinic
Sodium Pertechnetate (99Tc) Injection Generator: 99mTc From Neutron-activation 99Mo v 99mTc From Fission 99Mo	NCT03002454	Cancer of Bone	99mTc MDP Injec...	18 Years -	University of Manitoba

Spots Global Cancer Trial Database for cancer of bone