Overview
A Blinded Study Evaluating the Accuracy and Safety of Cyclotron-produced 99mTc in Adult Patients
Status:
Completed
Completed
Trial end date:
2017-04-01
2017-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate technetium-99m (99mTc) pertechnetate produced by a cyclotron as a replacement for 99mTc pertechnetate obtained from a generator containing the parent isotope Molybdenum-99 (99Mo). 99mTc pertechnetate is currently used in nuclear medicine departments across the country. 99Mo is produced by a number of ageing nuclear reactors across the world and severe shortages of the isotope have occurred in the past few years. Cyclotron-produced 99mTc offers an alternative decentralized production method on a regional basis. Since the manufacturing process is different, the safety and efficacy of cyclotron-produced 99mTc pertechnetate must be evaluated in human subjects to enable its routine clinical use.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
British Columbia Cancer AgencyCollaborators:
Canadian Institutes of Health Research (CIHR)
Centre for Probe Development and Commercialization
Lawson Health Research Institute
Natural Resources, Canada
TRIUMF
Criteria
Inclusion Criteria:- WHO performance status 0-2
- Older than the age of majority in the province where the study is performed, and be
able to consent to the project
- Ambulatory and able to lie supine for the duration of the examination.
- Able and willing to return for a subsequent visit within 7 days to undergo a repeat
examination and participate in a follow-up phone call to monitor for adverse events.
Subject referred for nuclear medicine examination for one of the following indications:
- Biochemically documented hyperthyroidism, referred for scintigraphy to evaluate the
differential diagnosis of hyperthyroidism or to plan radioiodine treatment.
- Referred for bone scintigraphy for the evaluation of metastases, fractures, or
inflammatory conditions. Subjects referred for a limited area (localized) bone scan
are eligible, provided they agree to undergo a whole-body scan as part of the
procedure.
Exclusion Criteria:
- Pregnant, planning to become pregnant within 30 days
- Severe evolving health problems (unstable coronary disease, liver failure, heart
failure, end-stage-renal failure, hospitalized subjects with severe medical
conditions) that may confound the assessment of adverse events.
For subjects evaluated for hyperthyroidism:
- Recent iodine-containing IV contrast administration (< 6 weeks)
- Recent amiodarone usage (< 8 weeks)
For subjects evaluated for bone scintigraphy:
• Recent trauma occurring less than 24 hours prior to the first 99mTc bone scintigraphy
examination, or between the first and second 99mTc bone scintigraphy examination.
Women who are breast-feeding are eligible to participate in this study, but must cease
breast-feeding for 24 hours following the 99mTc examinations. They can draw their milk and
discard it during this period, and use either formula or previously collected milk to feed
their child.