Trial Outcomes & Findings for Sodium Pertechnetate (99Tc) Injection Generator: 99mTc From Neutron-activation 99Mo v 99mTc From Fission 99Mo (NCT NCT03002454)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

4 participants

Primary outcome timeframe

60 days

Results posted on

2017-10-03

Participant Flow

Oncologic bone imaging subjects screened and enrolled at Health Sciences Centre, Winnipeg, Manitoba from August to November 2017.

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.

Participant milestones

Participant milestones
Measure	99mTc MDP Injection:Neutron-bombardment 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.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	99mTc MDP Injection:Neutron-bombardment n=4 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	61.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	99mTc MDP Injection:Neutron-bombardment n=4 Participants 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.
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.	4 Participants

Adverse Events

99mTc MDP Injection:Fission

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

99mTc MDP Injection:Neutron-bombardment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sandor Demeter

Winnipeg Regional Health Authority

Phone: 1 (204) 787-3375

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place