A Blinded Study Evaluating the Accuracy and Safety of Cyclotron-produced 99mTc in Adult Patients
Hyperthyroidism
About this trial
This is an interventional diagnostic trial for Hyperthyroidism focused on measuring Osteogenesis
Eligibility 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.
Sites / Locations
- Vancouver General Hospital - Nuclear Medicine
- Hamilton Health Sciences Centre
- London Regional Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Other
Other
Evaluation of hyperthyroidism
Evaluation of altered osteogenesis by bone scintigraphy
For the evaluation of hyperthyroidism each research subject will undergo imaging using both cyclotron-produced 99mTc and the current standard method used at the site for thyroid imaging (either 123I or generator-produced 99mTc). Each study will be performed on a separate day, with flexibility to schedule either study first.
For the evaluation of altered osteogenesis by bone scintigraphy each research subject will serve as his/her own control, and undergo imaging using both generator- and cyclotron-produced 99mTc. Each study will be performed on a separate day, with flexibility to schedule either study first.