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

NCT03002454 | Terminated Phase 3 Results

• 1 other identifier: NA 99Mo 001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Bone

Keywords

99mTc Pertechnetate; Sodium Pertechnetate; Technetium; Molybdenum; MDP; neutron activation

Outcome Measures

Primary Outcomes (1)

• 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.

  60 days

Study Arms (1)

99mTc MDP Injection:neutron-bombardment

EXPERIMENTAL

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

Drug: 99mTc MDP Injection:neutron-bombardment

Interventions

99mTc MDP Injection:neutron-bombardment DRUG

Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.

Also known as: Sodium Pertechnetate (99Tc) Injection Generator (neutron)

99mTc MDP Injection:neutron-bombardment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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). -

Sponsors & Collaborators

• University of Manitoba: lead
• Winnipeg Regional Health Authority: collaborator

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Sodium Pertechnetate Tc 99m; Neutrons

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Technetium Compounds; Inorganic Chemicals; Nucleons; Elementary Particles; Physical Phenomena

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Sandor Demeter
• Organization: Winnipeg Regional Health Authority

sdemeter@hsc.mb.ca

1 (204) 787-3375

Study Officials

• Sandor J Demeter, MSc MD FRCPC

  Winnipeg Regional Health Authority

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Nuclear Medicine

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 23, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 3, 2017
• Results First Posted: October 3, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)