Altered biodistribution in investigational images versus standard images.

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.

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

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). -

Reported Adverse Events (AEs) for the overall study include events starting on or after study start date and on or before study close date.

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.

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.