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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Cancer of Bone
Intervention Drug: 99mTc MDP Injection:neutron-bombardment
Enrollment 4
Recruitment Details Oncologic bone imaging subjects screened and enrolled at Health Sciences Centre, Winnipeg, Manitoba from August to November 2017.
Pre-assignment Details 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
Hide 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
Arm/Group Title 99mTc MDP Injection:Neutron-bombardment
Hide 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 Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  75.0%
>=65 years
1
  25.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
61.5
(44 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 4 participants
4
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.
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 99mTc MDP Injection:Neutron-bombardment
Comments [Not Specified]
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.

Other Statistical Analysis No statistical analysis - insufficient study population
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
99mTc MDP Injection:Fission 99mTc MDP Injection:Neutron-bombardment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
99mTc MDP Injection:Fission 99mTc MDP Injection:Neutron-bombardment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Sandor Demeter
Organization: Winnipeg Regional Health Authority
Phone: 1 (204) 787-3375
Responsible Party: Dr. Sandor J. Demeter, University of Manitoba
ClinicalTrials.gov Identifier: NCT03002454     History of Changes
Other Study ID Numbers: NA 99Mo 001
First Submitted: December 12, 2016
First Posted: December 23, 2016
Results First Submitted: January 13, 2017
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017