Coronary Artery DiseasePhase 1NCT00733460
A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PET
A Phase 1 study testing BFPET in people with Coronary Artery Disease, run by Fluoropharma, Inc. at 1 site in United States.
Trial summary
Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery Disease (CAD) patients , male or female and of age ranging between 20-80 years old. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- BFPET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2012
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must provide written informed consent prior to any study related procedures;
- Subjects must be ≥ 20 and ≤ 80 years of age;
- Subjects must have history of CAD documented by an abnormal stress myocardial perfusion imaging (MPI) study and cardiac catheterization within 6 months of the BFPET studyExclusion Criteria
Who cannot join
- 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;
- Any exposure to any investigational drugs within four (4) weeks prior to Visit 1;
- Any exposure to investigational radiopharmaceuticals within four (4) weeks prior to the date of Visit 1;
- Any new prescription medications within four (4) weeks of Visit 1;
- Subject has a Positive (+) Serum Pregnancy Test, or the possibility of pregnancy cannot be ruled out prior to dosing or is breast-feeding. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH.
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- Subject has experienced any allergic reaction to similar radiofluorinated compounds or agents.
- 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 6 months;
- Percutaneous coronary intervention (PCI), with stent placement within six months;
- Blood pressure over 180/100;
- Acute changes in ECG;
- 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 canula);
- History of Diabetes Mellitus;
- Serum creatinine > 2 mg/dL;
- All cancer 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;
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 BFPET as a Potential Myocardial Perfusion Imaging (MPI) Agent for PET
Safety and dosimetry of BFPET™ will be evaluated in healthy volunteers and Coronary Artery Disease (CAD) patients , male or female and of age ranging between 20-80 years old.
Read the detailed description
Study Procedures:
Visit 1: Screening - Eligibility determination
Visit 2 (within 14 days post screening): Injection of BFPET™ and PET Imaging
Visit 3 (within 24-48 hours post dose): Follow-up Visit
- Conditions
- Coronary Artery Disease
- Being tested
- BFPET
- Keywords
- BFPET, Coronary Artery Disease, Myocardial Perfusion Imaging, 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.
BFPETDrug
| Study group | Role | What they receive |
|---|---|---|
| BF-PET | Experimental | Not described Receives: Drug: BFPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure. Safety Biodistribution Radiation dosimetry
Change in vital signs, physical examination, ECG measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose.
Change in 12-lead Electrocardiogram measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose.
Change in 24-hour Holter (initiated 2 hours pre-dose, continuous for 24 hours, time stop recorded.
Change in dosimetry sampling (blood and urine)blood measured at time 0 (immediately following injection), 1,5, 15, 30, 60, 90 minutes.
Adverse event assessment immediate post dose, 24-48 hours and 7 days post-dose.
Measured: pre-dose, post-dose 0, 1, 5, 15, 30, 60 and 90 minutes, 2 hours, 24-48 hours post-dose and 7 days post-dose.
Secondary outcomes (1)
Performance characteristics of BFPET as a PET tracer for myocardial imaging.
Whole body imaging measures radiation dosimetry at rest and under pharmacologic stress
Measured: 30, 60, 120, and 240 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2012
- Study completionJan 2012
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluoropharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Gewirtz, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733460
- Sponsor's protocol ID
- BFPET P-01
- Status last verified
- Jun 2013
- First submitted
- 12 Aug 2008
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 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 BFPET as a Potential Myocardial Perfusion Imaging (MPI) Agent for PET
- ClinicalTrials.gov ID
- NCT00733460
- Acronym / sponsor ID
- BFPET P-01
- Conditions
- Coronary Artery Disease
- Keywords
- BFPET, Coronary Artery Disease, Myocardial Perfusion Imaging, Radiation Dosimetry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fluoropharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 13 Aug 2008 (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 BFPET™ will be evaluated in healthy volunteers and Coronary Artery Disease (CAD) patients , male or female and of age ranging between 20-80 years old.
Detailed description
Study Procedures:
Visit 1: Screening - Eligibility determination
Visit 2 (within 14 days post screening): Injection of BFPET™ and PET Imaging
Visit 3 (within 24-48 hours post dose): Follow-up Visit
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BF-PET | Experimental | Drug: BFPET |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must provide written informed consent prior to any study related procedures;
- Subjects must be ≥ 20 and ≤ 80 years of age;
- Subjects must have history of CAD documented by an abnormal stress myocardial perfusion imaging (MPI) study and cardiac catheterization within 6 months of the BFPET studyExclusion Criteria
Key exclusion criteria (23 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;
- Any exposure to any investigational drugs within four (4) weeks prior to Visit 1;
- Any exposure to investigational radiopharmaceuticals within four (4) weeks prior to the date of Visit 1;
- Any new prescription medications within four (4) weeks 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 |
|---|---|---|
| BFPET | Drug | BF-PET |
Primary outcome
Change in blood pressure. Safety Biodistribution Radiation dosimetry
Time frame: pre-dose, post-dose 0, 1, 5, 15, 30, 60 and 90 minutes, 2 hours, 24-48 hours post-dose and 7 days post-dose.
Change in vital signs, physical examination, ECG measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose. Change in 12-lead Electrocardiogram measured within 14 days of screening, immediate pre-dose, post-dose and 24-48 hours post-dose. Change in 24-hour Holter (initiated 2 hours pre-dose, continuous for 24 hours, time stop recorded. Change in dosimetry sampling (blood and urine)blood measured at time 0 (immediately following injection), 1,5, 15, 30, 60, 90 minutes. Adverse event assessment immediate post dose, 24-48 hours and 7 days post-dose.
1 secondary outcome
Performance characteristics of BFPET as a PET tracer for myocardial imaging.
Time frame: 30, 60, 120, and 240 seconds.
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 10 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.
Henry Gewirtz, M.D. 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 BFPET 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 3 inclusion and 23 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 10 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 blood pressure. Safety Biodistribution Radiation dosimetry (time frame: pre-dose, post-dose 0, 1, 5, 15, 30, 60 and 90 minutes, 2 hours, 24-48 hours post-dose and 7 days post-dose.). 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 10 Jun 2013.