Cancer of Bone
Conditions
Keywords
99mTc Pertechnetate, Sodium Pertechnetate, Technetium, Molybdenum, MDP, neutron activation
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
Interventions
DRUG99mTc MDP Injection:neutron-bombardment
Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.
Sponsors
Winnipeg Regional Health Authority
University of Manitoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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). -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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.
99mTc MDP Injection:neutron-bombardment: Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | 99mTc MDP Injection:Neutron-bombardment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 61.5 years |
| Region of Enrollment Canada | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 99mTc MDP Injection:Neutron-bombardment | 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 |