Back to results

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

Primary Purpose

Cancer of Bone

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

99mTc MDP Injection:neutron-bombardment

About this trial

This is an interventional diagnostic trial for Cancer of Bone focused on measuring 99mTc Pertechnetate, Sodium Pertechnetate, Technetium, Molybdenum, MDP, neutron activation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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). -

Sites / Locations

Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

99mTc MDP Injection:neutron-bombardment

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03002454

First Posted

December 12, 2016

Last Updated

May 3, 2017

Sponsor

University of Manitoba

Collaborators

Winnipeg Regional Health Authority

1. Study Identification

Unique Protocol Identification Number

NCT03002454

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

Altered biodistribution in investigational images versus standard images.

Study Start Date

August 2016 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Manitoba

Collaborators

Winnipeg Regional Health Authority

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of Bone

Keywords

99mTc Pertechnetate, Sodium Pertechnetate, Technetium, Molybdenum, MDP, neutron activation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

99mTc MDP Injection:neutron-bombardment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

99mTc MDP Injection:neutron-bombardment

Other Intervention Name(s)

Sodium Pertechnetate (99Tc) Injection Generator (neutron)

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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). -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandor J Demeter, MSc MD FRCPC

Organizational Affiliation

Winnipeg Regional Health Authority

Official's Role

Principal Investigator

Facility Information:

Facility Name

Health Sciences Centre

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs