An interventional study of Cyclotron-produced 99mTc and Generator-produced 99mTc in Hyperthyroidism, sponsored by British Columbia Cancer Agency. Completed at 3 sites in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by British Columbia Cancer Agency · Not applicable, Interventional, and Diagnostic
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.
115 studies on the registry are indexed under Hyperthyroidism; 28 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 57 interventional studies indexed under Hyperthyroidism.
Browse Hyperthyroidism studies →British Columbia Cancer Agency is the lead sponsor of 152 studies on the registry; 33 are open to participants now.
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Subject referred for nuclear medicine examination for one of the following indications:
Exclusion Criteria:
For subjects evaluated for hyperthyroidism:
For subjects evaluated for bone scintigraphy:
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.
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.
Drug: Cyclotron-produced 99mTc · Drug: Generator-produced 99mTc
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.
Drug: Cyclotron-produced 99mTc · Drug: Generator-produced 99mTc
Each research subject will serve as his/her own control, and will undergo imaging using both generator- and cyclotron-produced 99mTc. The study will follow the usual clinical procedure for routine imaging in the nuclear medicine department. All subjects will be contacted by phone or in person the day following the injection of both generator and cyclotron-produced 99mTc to monitor for potential adverse events.
Each research subject will serve as his/her own control, and will undergo imaging using both generator- and cyclotron-produced 99mTc. The study will follow the usual clinical procedure for routine imaging in the nuclear medicine department. All subjects will be contacted by phone or in person the day following the injection of both generator and cyclotron-produced 99mTc to monitor for potential adverse events.
Agreement rate of the blinded read of scintiscans between cyclotronproduced 99mTc (CP) and the standard of care (SOC) in the diagnosis of hyperthyroidism
The result of the standard of care test and cyclotron-produced 99mTc pertechnetate will be compiled in a 2 x 2 table, and the corresponding proportions will be compared. The accuracy of the thyroid examinations will be compared to a clinical standard of care consisting of a combination of physical examination, laboratory testing, ultrasound evaluation (when available) and short-term clinical follow-up at 12 weeks. The accuracy of cyclotron-produced 99mTc will be compared to the accuracy of generator-produced 99mTc or 123I, using a non-inferiority test of correlated proportions.
Time frame: 12 weeks
Blinded subjective comparison of image quality between cyclotron- and generator-produced 99mTc using a 5-point Likert scale.
For the subjective evaluation of image quality, data will be scored on a 5-point Likert scale, evaluating independently and blindly cyclotron- and generator-produced 99mTc. The scores on this ordinal scale will be compared using a one-sided Mann-Whitney test for paired samples.
Time frame: 1 year
The target-to-background ratio
For quantitative evaluation of image contrast, the target-to-background ratio will be calculated by measuring the activity in the organ of interest (long bones). The target-to-background ratios will be compared using a one-sided paired t-test.
Time frame: 1 year
Number of participants with 99mTc-related adverse events as assessed by abnormal vital sign measurement.
Vital signs (blood pressure, heart rate and pulse oximetry) will be measured at three time points (before and after injection, and 1 hour after the injection). All values that fall outside of the normal parameters will be assessed by a physician and reported as an adverse event.
Time frame: 1 hour
Number of participants with self-reported 99mTc-related adverse event.
Patients will be contacted by phone 24 hours after the 68Ga-DOTATOC PET/CT scan to see if they experienced any adverse events. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.
Time frame: 24 hours
The record gives a start of Oct 2015, a primary completion of Apr 2017 and a completion of Apr 2017. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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