NCT02514187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 21, 2023

Status Verified

December 1, 2018

Enrollment Period

1.5 years

First QC Date

July 27, 2015

Last Update Submit

February 17, 2023

Conditions

Hyperthyroidism

Keywords

Osteogenesis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Blinded subjective comparison of image quality between cyclotron- and generator-produced 99mTc using a 5-point Likert scale.

    1 year

  • The target-to-background ratio

    1 year

  • Number of participants with 99mTc-related adverse events as assessed by abnormal vital sign measurement.

    1 hour

  • Number of participants with self-reported 99mTc-related adverse event.

    24 hours

Study Arms (2)

Evaluation of hyperthyroidism

OTHER

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 99mTcDrug: Generator-produced 99mTc

Evaluation of altered osteogenesis by bone scintigraphy

OTHER

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 99mTcDrug: Generator-produced 99mTc

Interventions

Cyclotron-produced 99mTcDRUG

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.

Evaluation of altered osteogenesis by bone scintigraphyEvaluation of hyperthyroidism
Generator-produced 99mTcDRUG

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.

Evaluation of altered osteogenesis by bone scintigraphyEvaluation of hyperthyroidism

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vancouver General Hospital - Nuclear Medicine

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Hamilton Health Sciences Centre

Hamilton, Ontario, L8N 4A6, Canada

Location

London Regional Health Sciences Centre

London, Ontario, N6G 2V4, Canada

Location

MeSH Terms

Conditions

Hyperthyroidism

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System Diseases

Study Officials

  • Francois Benard, MD

    BC Cancer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2015

First Posted

August 3, 2015

Study Start

October 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 21, 2023

Record last verified: 2018-12

Locations

CA(3)