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

Primary Purpose

Hyperthyroidism

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cyclotron-produced 99mTc
Generator-produced 99mTc
Sponsored by
British Columbia Cancer Agency
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hyperthyroidism focused on measuring Osteogenesis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Other

Other

Arm Label

Evaluation of hyperthyroidism

Evaluation of altered osteogenesis by bone scintigraphy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 27, 2015
Last Updated
February 17, 2023
Sponsor
British Columbia Cancer Agency
Collaborators
Centre for Probe Development and Commercialization, Lawson Health Research Institute, TRIUMF, Canadian Institutes of Health Research (CIHR), Natural Resources, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02514187
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
Centre for Probe Development and Commercialization, Lawson Health Research Institute, TRIUMF, Canadian Institutes of Health Research (CIHR), Natural Resources, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthyroidism
Keywords
Osteogenesis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation of hyperthyroidism
Arm Type
Other
Arm Description
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.
Arm Title
Evaluation of altered osteogenesis by bone scintigraphy
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclotron-produced 99mTc
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Generator-produced 99mTc
Intervention Description
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.
Primary Outcome Measure Information:
Title
Agreement rate of the blinded read of scintiscans between cyclotronproduced 99mTc (CP) and the standard of care (SOC) in the diagnosis of hyperthyroidism
Description
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
Secondary Outcome Measure Information:
Title
Blinded subjective comparison of image quality between cyclotron- and generator-produced 99mTc using a 5-point Likert scale.
Description
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
Title
The target-to-background ratio
Description
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
Title
Number of participants with 99mTc-related adverse events as assessed by abnormal vital sign measurement.
Description
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
Title
Number of participants with self-reported 99mTc-related adverse event.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Benard, MD
Organizational Affiliation
BC Cancer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital - Nuclear Medicine
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Hamilton Health Sciences Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
London Regional Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2V4
Country
Canada

12. IPD Sharing Statement

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

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