Thyroid NeoplasmsPhase 2NCT01747512
An Imaging Study in Patients With Thyroid Cancer or Head and Neck Cancer With Pertechnetate Made in a Cyclotron (C-PERT)
A Phase 2 study testing C-PERT and G-PERT in people with Thyroid Neoplasms and Head and Neck Neoplasms, run by AHS Cancer Control Alberta.
Trial summary
Doctors at the Cross Cancer Institute have developed a new method of producing 99mTc Pertechnetate in a cyclotron unit. A study done at the Cross Cancer Institute in 2011 with ten patients using this imaging agent showed that it was safe and produced images with the same pattern as generator produced Pertechnetate. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Thyroid Neoplasms, Head and Neck Neoplasms
- What is being tested?
- C-PERT and G-PERT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento May 2013
- Phase
- Phase 2
- 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
- thyroid cancer, or
- Head and Neck cancer for salivary gland transfer
- age 18-79
- biochemical parameters < 5x ULN
- WBC > 3.0/uL
- ANC > 1.5/uL
Show all 9Show fewer
- platelets > 75,000/uL
- hemoglobin > 10 g/dL
- Karnofsky 50-100
Who cannot join
- nursing or pregnant females
- < 18 or > 79 Years
- uncontrolled asthma
- acute iritis
- narrow angle glaucoma
- previous radiation to head/neck
About this study
Official title: A Phase II/III Study of Cyclotron-produced Tc-99m Pertechnetate (C-PERT) Efficacy and Safety in Patients With Conformed and Suspected Thyroid Cancer or Head and Neck Cancer
Doctors at the Cross Cancer Institute have developed a new method of producing 99mTc Pertechnetate in a cyclotron unit. A study done at the Cross Cancer Institute in 2011 with ten patients using this imaging agent showed that it was safe and produced images with the same pattern as generator produced Pertechnetate. This study is now being done in larger numbers of patients to again show that the imaging pattern of both agents is the same, and to again demonstrate its safety.
Read the detailed description
To demonstrate the efficacy of cyclotron-produced Tc-99m pertechnetate (C-PERT; manufactured by the Edmonton PET Centre/ERC) in comparison to generator-produced Tc-99m pertechnetate (G-PERT; from approved commercial source; using qualitative and quantitative clinical imaging biodistribution data.
- Conditions
- Thyroid Neoplasms, Head and Neck Neoplasms
- Being tested
- C-PERT, G-PERT
- Keywords
- 99mTc Pertechnetate, thyroidectomy, thyroid neoplasms
- Medical subject headings
- Thyroid Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-PERTDrug
Patients with thyroid and Head and Neck cancer
G-PERTDrug
Patients with thyroid and Head and Neck cancer
| Study group | Role | What they receive |
|---|---|---|
| C-PERT | Active comparator | 45 patients with cancer Receives: Drug: C-PERT |
| G-PERT | Active comparator | 65 patients with cancer Receives: Drug: G-PERT |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the efficacy of C-PERT (manufactured by the Edmonton PET Centre/ERC) in comparison to G-PERT (fromm approved commercial sources) using qualitative and quantitative clinical imaging biodistribtion data.
Measured: 5 months
Secondary outcomes (1)
To evaluate the safety of C-PERT from adverse event data
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Primary completionMay 2013 (estimated)
Why it stopped: Study was not initiated
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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Alexander McEwan, MB, FRCPC, Principal investigator, Professor, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747512
- Sponsor's protocol ID
- DX-CPERT-002
- Status last verified
- Nov 2017
- First submitted
- 10 Dec 2012
- 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 II/III Study of Cyclotron-produced Tc-99m Pertechnetate (C-PERT) Efficacy and Safety in Patients With Conformed and Suspected Thyroid Cancer or Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01747512
- Acronym / sponsor ID
- DX-CPERT-002
- Conditions
- Thyroid Neoplasms, Head and Neck Neoplasms
- Keywords
- 99mTc Pertechnetate, thyroidectomy, thyroid neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Primary completion
- May 2013 (estimated)
- First posted
- 11 Dec 2012 (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.
Doctors at the Cross Cancer Institute have developed a new method of producing 99mTc Pertechnetate in a cyclotron unit. A study done at the Cross Cancer Institute in 2011 with ten patients using this imaging agent showed that it was safe and produced images with the same pattern as generator produced Pertechnetate. This study is now being done in larger numbers of patients to again show that the imaging pattern of both agents is the same, and to again demonstrate its safety.
Detailed description
To demonstrate the efficacy of cyclotron-produced Tc-99m pertechnetate (C-PERT; manufactured by the Edmonton PET Centre/ERC) in comparison to generator-produced Tc-99m pertechnetate (G-PERT; from approved commercial source; using qualitative and quantitative clinical imaging biodistribution data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-PERT | Active comparator | Drug: C-PERT45 patients with cancer |
| G-PERT | Active comparator | Drug: G-PERT65 patients with cancer |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- thyroid cancer, or
- Head and Neck cancer for salivary gland transfer
- age 18-79
- biochemical parameters < 5x ULN
- WBC > 3.0/uL
Key exclusion criteria (6 listed)
- nursing or pregnant females
- < 18 or > 79 Years
- uncontrolled asthma
- acute iritis
- narrow angle glaucoma
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 |
|---|---|---|
| C-PERTPatients with thyroid and Head and Neck cancer | Drug | C-PERT |
| G-PERTPatients with thyroid and Head and Neck cancer | Drug | G-PERT |
Primary outcome
To demonstrate the efficacy of C-PERT (manufactured by the Edmonton PET Centre/ERC) in comparison to G-PERT (fromm approved commercial sources) using qualitative and quantitative clinical imaging biodistribtion data.
Time frame: 5 months
1 secondary outcome
To evaluate the safety of C-PERT from adverse event data
Time frame: 5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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, FRCPC principal investigator
Professor, Department of Oncology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing C-PERT and G-PERT in people with Thyroid Neoplasms and Head and Neck Neoplasms, run by AHS Cancer Control Alberta.
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 9 inclusion and 6 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: withdrawn, 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.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
To demonstrate the efficacy of C-PERT (manufactured by the Edmonton PET Centre/ERC) in comparison to G-PERT (fromm approved commercial sources) using qualitative and quantitative clinical imaging biodistribtion data. (time frame: 5 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.