Prostate CancerPhase 1NCT02844647
Hyperpolarized Carbon-13 Imaging of Metastatic Prostate Cancer
A Phase 1 study testing Hyperpolarized Pyruvate (13C) in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
A pilot study with a group of up to 10 men with CRPC about to embark on a 6-month course of treatment with radium 223. Study participants will undergo anatomical MR imaging combined with the new hyperpolarized MRI (1 hour exam) prior to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hyperpolarized Pyruvate (13C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2016to 23 Mar 2023
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with bone-metastatic CRPC before starting the first dose of radium 223 therapy
- Laboratory requirements:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x109/L
- Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
- Total bilirubin level ≤ 1.5 institutional upper limit of normal (ULN)
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- ASAT and ALAT ≤ 2.5 ULN
- • Creatinine ≤ 1.5 ULN
- Albumin >25 g/L
- Eastern Cooperative Oncology Group Status of 0 or 1
Who cannot join
- Unable to give valid informed consent
- Contraindication for MRI as per Sunnybrook MRI questionnaire (Appendix 1).
- Claustrophobia
- Body mass index of less than 18.5 or greater than 32
- Congestive heart failure, a past or present medical history of clinically significant electrocardiogram (EKG) abnormalities, which may include QT prolongation, a family history of prolonged QT interval syndrome, or a myocardial infarction (MI) within the past 12 months with ensuing unstable EKG, or ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year
Trial locations and contacts
1 site in 1 country.
About this study
A pilot study with a group of up to 10 men with CRPC about to embark on a 6-month course of treatment with radium 223. Study participants will undergo anatomical MR imaging combined with the new hyperpolarized MRI (1 hour exam) prior to treatment.
Read the detailed description
"Hyperpolarization" of low natural abundance species such as 13C, offers the potential of extracting metabolic information by real-time imaging of biochemical reactions within the body. In this project, the investigators focus on prostate cancer, specifically late-stage disease, as management of these patients would benefit from a new imaging method that enables improved therapy selection, planning and monitoring.
For imaging the lactate distribution in bone-metastatic prostate cancer, 3D coverage of a large field-of-view is required in order to cover the vertebral column (the most common site of metastases). To enable this, the investigators have developed methods using a large-volume transmitter and multi-channel receiver system for 3-dimensional 13C metabolic imaging in these patients. The image resolution and encoding matrix were tailored to the required 3D coverage of the vertebral column.
At the end of this study, the investigators will have the methodology, hardware and clinical-research workflow needed to evaluate 13C-lactate imaging as a new tool to help patients with metastatic prostate cancer. The investigators would be the first in the world to apply 13C metabolic MRI to bone metastases. Although the investigators propose to study patients who are starting a 6-month course of treatment with radium 223, in this project, this proof-of-concept study may also lead to a larger clinical trial at different points in the treatment pathway, such as prior to deciding between treatment with cytotoxic agents versus drugs that target the androgen axis such as abiraterone.
- Conditions
- Prostate Cancer
- Being tested
- Hyperpolarized Pyruvate (13C)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Pyruvate (13C)Other
MRI contrast agent
| Study group | Role | What they receive |
|---|---|---|
| MRI w/ Hyperpolarized Pyruvate (13C) | Experimental | "Hyperpolarization" of low natural abundance species such as 13C, when injected offers the potential of extracting metabolic information by real-time MR imaging of biochemical reactions within the body. The biochemical reactions, including lactate production, will be measured using MRI. Receives: Other: Hyperpolarized Pyruvate (13C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Images of lactate, bicarbonate and pyruvate in patients with bone-metastatic CRPC measured by MRI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start15 Dec 2016
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Why it stopped: Lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Cunningham, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844647
- Sponsor's protocol ID
- 432-2015
- Status last verified
- Mar 2023
- First submitted
- 13 Jun 2016
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized Carbon-13 Imaging of Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT02844647
- Acronym / sponsor ID
- 432-2015
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 26 Jul 2016 (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.
A pilot study with a group of up to 10 men with CRPC about to embark on a 6-month course of treatment with radium 223. Study participants will undergo anatomical MR imaging combined with the new hyperpolarized MRI (1 hour exam) prior to treatment.
Detailed description
"Hyperpolarization" of low natural abundance species such as 13C, offers the potential of extracting metabolic information by real-time imaging of biochemical reactions within the body. In this project, the investigators focus on prostate cancer, specifically late-stage disease, as management of these patients would benefit from a new imaging method that enables improved therapy selection, planning and monitoring.
For imaging the lactate distribution in bone-metastatic prostate cancer, 3D coverage of a large field-of-view is required in order to cover the vertebral column (the most common site of metastases). To enable this, the investigators have developed methods using a large-volume transmitter and multi-channel receiver system for 3-dimensional 13C metabolic imaging in these patients. The image resolution and encoding matrix were tailored to the required 3D coverage of the vertebral column.
At the end of this study, the investigators will have the methodology, hardware and clinical-research workflow needed to evaluate 13C-lactate imaging as a new tool to help patients with metastatic prostate cancer. The investigators would be the first in the world to apply 13C metabolic MRI to bone metastases. Although the investigators propose to study patients who are starting a 6-month course of treatment with radium 223, in this project, this proof-of-concept study may also lead to a larger clinical trial at different points in the treatment pathway, such as prior to deciding between treatment with cytotoxic agents versus drugs that target the androgen axis such as abiraterone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI w/ Hyperpolarized Pyruvate (13C) | Experimental | Other: Hyperpolarized Pyruvate (13C)"Hyperpolarization" of low natural abundance species such as 13C, when injected offers the potential of extracting metabolic information by real-time MR imaging of biochemical reactions within the body. The biochemical reactions, including lactate production, will be measured using MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men with bone-metastatic CRPC before starting the first dose of radium 223 therapy
- Laboratory requirements:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x109/L
- Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
Key exclusion criteria (5 listed)
- Unable to give valid informed consent
- Contraindication for MRI as per Sunnybrook MRI questionnaire (Appendix 1).
- Claustrophobia
- Body mass index of less than 18.5 or greater than 32
- Congestive heart failure, a past or present medical history of clinically significant electrocardiogram (EKG) abnormalities, which may include QT prolongation, a family history of prolonged QT interval syndrome, or a myocardial infarction (MI) within the past 12 months with ensuing unstable EKG, or ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year
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 |
|---|---|---|
| Hyperpolarized Pyruvate (13C)MRI contrast agent | Other | MRI w/ Hyperpolarized Pyruvate (13C) |
Primary outcome
Images of lactate, bicarbonate and pyruvate in patients with bone-metastatic CRPC measured by MRI
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Lack of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Charles Cunningham, PhD principal investigator
Sunnybrook Research Institute
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 Hyperpolarized Pyruvate (13C) in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre 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 5 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: stopped early, as of the sponsor's last update on 28 Mar 2023. 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 was stopped early (reason given: Lack of participants). Results are not available in the source record.
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?
Images of lactate, bicarbonate and pyruvate in patients with bone-metastatic CRPC measured by MRI (time frame: 1 year). 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 28 Mar 2023.