Clinical trial NCT02514187: A Blinded Study Evaluating the Accuracy and Safety of Cyclotron-produced 99mTc in Adult Patients
Official title: A Blinded Study Evaluating the Accuracy and Safety of Cyclotron-produced 99mTc in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperthyroidism
Keywords: Osteogenesis
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Centre for Probe Development and Commercialization
name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: TRIUMF
name: Canadian Institutes of Health Research (CIHR)
name: Natural Resources, Canada
First posted: 2015-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


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.

Primary outcomes:
measure: Agreement rate of the blinded read of scintiscans between cyclotronproduced 99mTc (CP) and the standard of care (SOC) in the diagnosis of hyperthyroidism
timeFrame: 12 weeks
Secondary outcomes:
measure: Blinded subjective comparison of image quality between cyclotron- and generator-produced 99mTc using a 5-point Likert scale.
timeFrame: 1 year
measure: The target-to-background ratio
timeFrame: 1 year
measure: Number of participants with 99mTc-related adverse events as assessed by abnormal vital sign measurement.
timeFrame: 1 hour
measure: Number of participants with self-reported 99mTc-related adverse event.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital - Nuclear Medicine
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Regional Health Sciences Centre
state: Ontario
Study officials:
affiliation: BC Cancer
name: Francois Benard, MD
role: PRINCIPAL_INVESTIGATOR
References: