Coronary Artery DiseasePhase 1NCT00413647
A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET™ in Detection of Coronary Artery Disease
A Phase 1 study testing CardioPET in people with Coronary Artery Disease, run by Fluoropharma, Inc. at 1 site in United States.
Trial summary
Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85. Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CardioPET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Feb 2008
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal Healthy Volunteers:
- Subject must provide written informed consent prior to any study related procedures
- Subjects must be between the ages of 50 and 85 years of age.
- Coronary Artery Disease (CAD) subjects:
- Subjects must provide written informed consent prior to any study related procedures;
- Subjects must be ≥ 50 and ≤ 85 years of age;
- Subject must have history of CAD documented by an exercise stress Myocardial Perfusion Imaging (MPI) study within 6 months documenting myocardial infarct without ischemia.
Who cannot join
- Normal Healthy Volunteers:
- Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
- Any clinically significant abnormality in the screening laboratory tests or ECG
- Fasting blood glucose level over 120 mg/dl
- Any exposure to any investigational drugs with four(4)weeks prior to Visit 1
- Any exposure to radiopharmaceuticals within four(4)weeks prior to the date of Visit 1
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- Any new prescription medications within four(4)weeks of Visit 1
- Subject has a Positive(+)Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH
- Coronary Artery Disease (CAD) Subjects:
- Subject has a Positive (+) Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing;
- Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
- Coronary artery bypass graft (CABG) within 1 year;
- Percutaneous coronary intervention (PCI), with stent placement within three months;
- Blood pressure over 180/100;
- Acute changes in ECG;
- Cardiac ischemia identified by MPI stress test;
- Recent (within 3 months) cardiac arrest, unstable angina, myocardial infarction, cerebro-vascular accident (CVA), any general anesthesia procedure, any surgical procedures;
- Any implanted pacemaker or defibrillator use within the last three months;
- Inability to remain in camera for approximately 60 minutes (Smokers and COPD are included as long as they can breath in PET camera and not taking O2 through nasal canola);
- History of Diabetes Mellitus;
- Serum creatinine > 2 mg/dL;
- All cancer and or chemotherapy patients;
- Body Mass Index (BMI) is over 35;
- Any exposure to any investigational drugs or medical device within four (4) weeks prior to imaging study;
- Any exposure to radiopharmaceuticals within four (4) weeks prior to the date of imaging study;
- High daily alcohol consumption over 4 alcohol drinks per day.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of CardioPET™ as a PET Tracer for Detection of Coronary Artery Disease
Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85. Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging only.
Read the detailed description
CardioPET™ is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body.
Study Procedures:
Visit 1: Screening - Eligibility determination
Visit 2: Injection and PET Imaging
Visit 3: Follow-up Visit
- Conditions
- Coronary Artery Disease
- Being tested
- CardioPET
- Keywords
- CardioPET, Coronary Artery Disease, Electrocardiogram, Radiation Dosimetry
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioPETDrug
| Study group | Role | What they receive |
|---|---|---|
| CardioPET | Experimental | Not described Receives: Drug: CardioPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment.
Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.
Measured: Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).
Secondary outcomes (2)
Performance characteristics of CardioPET as a PET tracer for myocardial imaging.
Normal healthy volunteers and CAD subjects for Cardiac Imaging Only.
Measured: 0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min.
Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data
Measured: Baseline, 15 second time frames for first 2 minutes, 1 min. time frame for next 8 min., 2 min frames for remainder of 60 min study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study startSep 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluoropharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan J. Fischman, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413647
- Sponsor's protocol ID
- CardioPET P-01
- Status last verified
- Jun 2013
- First submitted
- 18 Dec 2006
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of CardioPET™ as a PET Tracer for Detection of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00413647
- Acronym / sponsor ID
- CardioPET P-01
- Conditions
- Coronary Artery Disease
- Keywords
- CardioPET, Coronary Artery Disease, Electrocardiogram, Radiation Dosimetry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Fluoropharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 20 Dec 2006 (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.
Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85. Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging only.
Detailed description
CardioPET™ is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body.
Study Procedures:
Visit 1: Screening - Eligibility determination
Visit 2: Injection and PET Imaging
Visit 3: Follow-up Visit
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CardioPET | Experimental | Drug: CardioPET |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must provide written informed consent prior to any study related procedures
- Subjects must be between the ages of 50 and 85 years of age.
- Subjects must provide written informed consent prior to any study related procedures;
- Subjects must be ≥ 50 and ≤ 85 years of age;
- Subject must have history of CAD documented by an exercise stress Myocardial Perfusion Imaging (MPI) study within 6 months documenting myocardial infarct without ischemia.
Key exclusion criteria (26 listed)
- Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
- Any clinically significant abnormality in the screening laboratory tests or ECG
- Fasting blood glucose level over 120 mg/dl
- Any exposure to any investigational drugs with four(4)weeks prior to Visit 1
- Any exposure to radiopharmaceuticals within four(4)weeks prior to the date of Visit 1
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 |
|---|---|---|
| CardioPET | Drug | CardioPET |
Primary outcome
Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment.
Time frame: Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).
Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.
2 secondary outcomes
Performance characteristics of CardioPET as a PET tracer for myocardial imaging.
Time frame: 0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min.
Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data
Time frame: Baseline, 15 second time frames for first 2 minutes, 1 min. time frame for next 8 min., 2 min frames for remainder of 60 min study.
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 12 Jun 2013.
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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.
Alan J. Fischman, MD, PhD principal investigator
Massachusetts General Hospital
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 CardioPET in people with Coronary Artery Disease, run by Fluoropharma, Inc. at 1 site in United States.
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 7 inclusion and 26 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 12 Jun 2013. 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 United States. 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?
Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment. (time frame: Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).). 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 12 Jun 2013.