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Trial record 34 of 4290 for:    bone tumors AND NOT metastatic

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

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ClinicalTrials.gov Identifier: NCT03002454
Recruitment Status : Terminated (Altered biodistribution in investigational images versus standard images.)
First Posted : December 23, 2016
Results First Posted : October 3, 2017
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Winnipeg Regional Health Authority
Information provided by (Responsible Party):
Dr. Sandor J. Demeter, University of Manitoba

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer of Bone Drug: 99mTc MDP Injection:neutron-bombardment Phase 3

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : August 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 99mTc MDP Injection:neutron-bombardment
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
Drug: 99mTc MDP Injection:neutron-bombardment
Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.
Other Name: Sodium Pertechnetate (99Tc) Injection Generator (neutron)




Primary Outcome Measures :
  1. 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. [ Time Frame: 60 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Oncology out-patients in whom an acceptable quality standard-of-care Technetium (99mTc) Medronate bone scan has been ordered or obtained within the last 28 days.
  • If female of child-bearing potential is outside of the window of 10 days since the last menstrual period, a negative serum pregnancy test is required.
  • Age greater than or equal to 18 years.

Exclusion Criteria:

  • Oncology out-patients in whom an acceptable quality standard-of-care Technetium (99mTc) Medronate bone scan has been ordered or obtained within the last 28 days.
  • If female of child-bearing potential is outside of the window of 10 days since the last menstrual period, a negative serum pregnancy test is required.
  • Age greater than or equal to 18 years.
  • Identified interval events which have occurred after the standard of care bone scan but prior to the administration of non-fission sourced Technetium (99mTc) Medronate which could influence or change bone scan uptake (e.g. skeletal trauma, orthopedic surgery, bone infection, or interval therapy (i.e. radiation therapy, non-maintenance chemotherapy). -

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): NCT03002454


Locations
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Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
Winnipeg Regional Health Authority
Investigators
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Principal Investigator: Sandor J Demeter, MSc MD FRCPC Winnipeg Regional Health Authority

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Responsible Party: Dr. Sandor J. Demeter, Head, Nuclear Medicine, University of Manitoba
ClinicalTrials.gov Identifier: NCT03002454     History of Changes
Other Study ID Numbers: NA 99Mo 001
First Posted: December 23, 2016    Key Record Dates
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Sandor J. Demeter, University of Manitoba:
99mTc Pertechnetate
Sodium Pertechnetate
Technetium
Molybdenum
MDP
neutron activation

Additional relevant MeSH terms:
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Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Sodium Pertechnetate Tc 99m
Technetium Tc 99m Medronate
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action