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

NCT ID: NCT03002454

Last Updated: 2017-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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

Conditions

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Cancer of Bone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

99mTc MDP Injection:neutron-bombardment

Intervention Type DRUG

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

Interventions

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99mTc MDP Injection:neutron-bombardment

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

Intervention Type DRUG

Other Intervention Names

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Sodium Pertechnetate (99Tc) Injection Generator (neutron)

Eligibility Criteria

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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). -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Winnipeg Regional Health Authority

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sandor J. Demeter

Head, Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandor J Demeter, MSc MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Winnipeg Regional Health Authority

Locations

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Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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NA 99Mo 001

Identifier Type: -

Identifier Source: org_study_id