Clinical trial · Interventional
Sodium Pertechnetate (99Tc) Injection Generator: 99mTc From Neutron-activation 99Mo v 99mTc From Fission 99Mo
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Altered biodistribution in investigational images versus standard images.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Bone | Malignant Bone Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTc MDP Injection:neutron-bombardment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 99mTc MDP Injection:neutron-bombardment
- 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
- interventionNames
- Drug: 99mTc MDP Injection:neutron-bombardment
Primary outcomes (1)
- measure
- 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.
- timeFrame
- 60 days
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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). -
References
Publications (0)
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