Thyroid NeoplasmsPhase 1NCT01437254
To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer
A Phase 1 study testing CPERT and GPERT in people with Thyroid Neoplasms, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The cyclotron production model of Tc-99m pertechnetate (CPERT) has received significant validation in the independent expert review conducted by Natural Resources Canada (NRCan) in the follow up to the Chalk River crisis. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- CPERT and GPERT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
- Have confirmed well differentiated thyroid cancer, post-thyroidectomy and pre-RAI
- Biochemical parameters as measured are required to be within 5 times the normal limits for age
- white blood cell count (WCB) > 3.0/µL
- absolute neutrophil count (ANC) > 1.5/µL
- Platelets > 75,000/µL
Show all 10Show fewer
- Hemoglobin > 10 g/dL
- Able and willing to follow instructions and comply with the protocol
- Provide written informed consent prior to participation in the study
- Karnofsky Performance Scale score of 50 - 100
Who cannot join
- Nursing or pregnant females
- Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the pre-treatment scan
- White blood cell count (WCB < 3.0/µL)
- absolute neutrophil count (ANC) < 1.5/µL
- Platelets < 75,000/µL
- Haemoglobin < 10 g/dL
Show all 9Show fewer
- unable and unwilling to follow instructions and comply with the protocol
- unable or unwilling to provide written informed consent prior to participation in the study
- Karnofsky Performance Scale score <50
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Cyclotron-produced Tc-99m Pertechnetate (CPERT) in Patients With Thyroid Cancer
The cyclotron production model of Tc-99m pertechnetate (CPERT) has received significant validation in the independent expert review conducted by Natural Resources Canada (NRCan) in the follow up to the Chalk River crisis. The University of Alberta's Edmonton PET Centre and the Edmonton Radiopharmaceutical Centre is a cyclotron / radiopharmacy unit, providing a safe, cost effective, unsubsidized, and reliable supply of radiopharmaceuticals to hospitals and clinics in Edmonton and northern Alberta. A Phase I study is proposed to show safety of CPERT as well as comparability with generator-produced Tc-99m pertechnetate (GPERT) in subjects with well differentiated thyroid carcinoma post-thyroidectomy and prior to planned I-131 Iodide treatment.
Read the detailed description
Patients who have had a thyroidectomy for cancer routinely have a Tc-99m Pertechnetate (GPERT) scan at the Cross Cancer Institute to check for thyroid tissue remnants prior to radioactive iodine therapy. The first 10 subjects will receive a CPERT whole body scan, and and 20 subsequent case-matched controls (2 for each CPERT subject, matched for age and gender) will receive a GPERT whole body scan. CPERT safety will be assessed by pre-injection and post-imaging collection of vital signs and blood samples (haematology and biochemistry). Adverse event collection will be done for both CPERT and GPERT subjects. The whole body biodistribution pattern of CPERT will be qualitatively compared to GPERT by two independent and blinded Nuclear Medicine physicians.
- Conditions
- Thyroid Neoplasms
- Being tested
- CPERT, GPERT
- Keywords
- 99mTc Pertechnetate, thyroidectomy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPERTDrug
Single 340 MBq CPERT scan in first 10 subjects
GPERTDrug
Single 340 MBq GPERT scan in up to 20 case-matched controls
| Study group | Role | What they receive |
|---|---|---|
| Arm Number 1 CPERT | Experimental | 1 CPERT scan, blood and vital sign collection Receives: Drug: CPERT |
| Arm Number 2 GPERT | Active comparator | 1 GPERT Scan Receives: Drug: GPERT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CPERT
CPERT safety will be assessed by evaluation of vital signs (pre-injection and post-imaging), blood haematology (pre-injection and post-imaging), SMA-12 clinical biochemistry profile (pre-injection and post-imaging) and collection of adverse events.
Measured: 7 months
Secondary outcomes (1)
Comparison of general biodistribution of CPERT and GPERT.
The whole body biodistribution pattern of CPERT will be compared to GPERT using two independent and blinded Nuclear Medicine physicians.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Resources, Canada, Edmonton PET Centre
- Responsible party
- Sponsor
- Investigators
- Alexander McEwan, MB, FCRPC, Principal investigator, Professor, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437254
- Sponsor's protocol ID
- DX-CPERT-001
- Status last verified
- Nov 2017
- First submitted
- 19 Sep 2011
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Cyclotron-produced Tc-99m Pertechnetate (CPERT) in Patients With Thyroid Cancer
- ClinicalTrials.gov ID
- NCT01437254
- Acronym / sponsor ID
- DX-CPERT-001
- Conditions
- Thyroid Neoplasms
- Keywords
- 99mTc Pertechnetate, thyroidectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Natural Resources, Canada, Edmonton PET Centre
- Study start
- Oct 2011 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cyclotron production model of Tc-99m pertechnetate (CPERT) has received significant validation in the independent expert review conducted by Natural Resources Canada (NRCan) in the follow up to the Chalk River crisis. The University of Alberta's Edmonton PET Centre and the Edmonton Radiopharmaceutical Centre is a cyclotron / radiopharmacy unit, providing a safe, cost effective, unsubsidized, and reliable supply of radiopharmaceuticals to hospitals and clinics in Edmonton and northern Alberta. A Phase I study is proposed to show safety of CPERT as well as comparability with generator-produced Tc-99m pertechnetate (GPERT) in subjects with well differentiated thyroid carcinoma post-thyroidectomy and prior to planned I-131 Iodide treatment.
Detailed description
Patients who have had a thyroidectomy for cancer routinely have a Tc-99m Pertechnetate (GPERT) scan at the Cross Cancer Institute to check for thyroid tissue remnants prior to radioactive iodine therapy. The first 10 subjects will receive a CPERT whole body scan, and and 20 subsequent case-matched controls (2 for each CPERT subject, matched for age and gender) will receive a GPERT whole body scan. CPERT safety will be assessed by pre-injection and post-imaging collection of vital signs and blood samples (haematology and biochemistry). Adverse event collection will be done for both CPERT and GPERT subjects. The whole body biodistribution pattern of CPERT will be qualitatively compared to GPERT by two independent and blinded Nuclear Medicine physicians.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Number 1 CPERT | Experimental | Drug: CPERT1 CPERT scan, blood and vital sign collection |
| Arm Number 2 GPERT | Active comparator | Drug: GPERT1 GPERT Scan |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
- Have confirmed well differentiated thyroid cancer, post-thyroidectomy and pre-RAI
- Biochemical parameters as measured are required to be within 5 times the normal limits for age
- white blood cell count (WCB) > 3.0/µL
- absolute neutrophil count (ANC) > 1.5/µL
Key exclusion criteria (9 listed)
- Nursing or pregnant females
- Biochemical parameters as measured outside 5 times the normal limits for age within 14 days of the pre-treatment scan
- White blood cell count (WCB < 3.0/µL)
- absolute neutrophil count (ANC) < 1.5/µL
- Platelets < 75,000/µL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPERTSingle 340 MBq CPERT scan in first 10 subjects | Drug | Arm Number 1 CPERT |
| GPERTSingle 340 MBq GPERT scan in up to 20 case-matched controls | Drug | Arm Number 2 GPERT |
Primary outcome
Safety of CPERT
Time frame: 7 months
CPERT safety will be assessed by evaluation of vital signs (pre-injection and post-imaging), blood haematology (pre-injection and post-imaging), SMA-12 clinical biochemistry profile (pre-injection and post-imaging) and collection of adverse events.
1 secondary outcome
Comparison of general biodistribution of CPERT and GPERT.
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander McEwan, MB, FCRPC principal investigator
Professor, Department of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPERT and GPERT in people with Thyroid Neoplasms, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CPERT (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.