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

Phase 3

Terminated

• Conditions: Cancer of Bone

• Registration Number: NCT03002454
• Lead Sponsor: 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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2016-11
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Study Completion: 2017-01
• Results First Submitted: 2017-01-13
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-03
• Last Update Submitted: 2017-05-03
• Results First Posted: 2017-10-03
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

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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). -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada