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

• Sponsor: University of Manitoba (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03002454
• Collaborator: Winnipeg Regional Health Authority (Other)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 0.8

Study Details

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• 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: Aug 1, 2016
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

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 Names: Sodium Pertechnetate (99Tc) Injection Generator (neutron)

Outcome Measures

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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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). -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Sciences Centre	Winnipeg	Manitoba	Canada	R3A 1R9

Sponsors and Collaborators

• University of Manitoba
• Winnipeg Regional Health Authority

Investigators

• Principal Investigator: Sandor J Demeter, MSc MD FRCPC, Winnipeg Regional Health Authority

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Sandor J. Demeter, Head, Nuclear Medicine, University of Manitoba
• ClinicalTrials.gov Identifier: NCT03002454
• Other Study ID Numbers: NA 99Mo 001
• First Posted: Dec 23, 2016
• Last Update Posted: Oct 3, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dr. Sandor J. Demeter, Head, Nuclear Medicine, University of Manitoba: 99mTc Pertechnetate; Sodium Pertechnetate; Technetium; Molybdenum; MDP; neutron activation
• Additional relevant MeSH terms: Bone Neoplasms; Sodium Pertechnetate Tc 99m; Technetium Tc 99m Medronate

Study Results

Participant Flow

Recruitment Details	Oncologic bone imaging subjects screened and enrolled at Health Sciences Centre, Winnipeg, Manitoba from August to November 2017.
Pre-assignment Detail	Previous bone imaging scan, within 3 to 28 days, using fission derived 99mTc MDP Injection to act as comparator for investigative drug (neutron-bombardment derived 99mTc MDP Injection) bone imaging scan of same subject.

Arm/Group Title	99mTc MDP Injection:Neutron-bombardment
Arm/Group Description	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.
Period Title: Overall Study
STARTED	4
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	99mTc MDP Injection:Neutron-bombardment
Arm/Group 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. 99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.
Overall Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 75%
>=65 years	1 25%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	61.5
Sex: Female, Male (Count of Participants)
Female	2 50%
Male	2 50%
Region of Enrollment (participants) [Number]
Canada	4 100%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	60 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	99mTc MDP Injection:Neutron-bombardment
Arm/Group 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. 99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.
Measure Participants	4
Count of Participants [Participants]	4 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	99mTc MDP Injection:Neutron-bombardment
	Comments
	Type of Statistical Test	Equivalence
	Comments	Control: 99mTc MDP Injection:fission Investigation: 99mTc MDP Injection:neutron-bombardment Anticipated sample size of 50 participants with sample size parameters of: Alpha 0.05 Power 80% Kappa of significance 0.7 - 0.8 Prevalence of abnormal bone scans 30% Actual study population of 4 participants with 4 out of 4 demonstrating gross abnormal biodistribution therefore the study was terminated and no statistical analysis was conducted.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		No statistical analysis - insufficient study population

Adverse Events

Time Frame	Reported Adverse Events (AEs) for the overall study include events starting on or after study start date and on or before study close date.
Adverse Event Reporting Description	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.
Arm/Group Title	99mTc MDP Injection:Fission		99mTc MDP Injection:Neutron-bombardment
Arm/Group Description	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.		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.
All Cause Mortality
	99mTc MDP Injection:Fission		99mTc MDP Injection:Neutron-bombardment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	99mTc MDP Injection:Fission		99mTc MDP Injection:Neutron-bombardment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	99mTc MDP Injection:Fission		99mTc MDP Injection:Neutron-bombardment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.