A Blinded Study Evaluating the Accuracy and Safety of Cyclotron-produced 99mTc in Adult Patients

Hyperthyroidism Clinical Trial

Official title:

A Blinded Study Evaluating the Accuracy and Safety of Cyclotron-produced 99mTc in Adult Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514187
• Other study ID #: H15-01132
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: April 2017

Study information

• Verified date: December 2018
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperthyroidism

Intervention

Drug:
• Cyclotron-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.
• 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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	London Regional Health Sciences Centre	London	Ontario
Canada	Vancouver General Hospital - Nuclear Medicine	Vancouver	British Columbia

Sponsors (6)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	Canadian Institutes of Health Research (CIHR), Centre for Probe Development and Commercialization, Lawson Health Research Institute, Natural Resources, Canada, TRIUMF

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 hour
Secondary	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.	24 hours