Coronary Artery DiseasePhase 2NCT02252783
BFPET for Regional Myocardial Perfusion Imaging
A Phase 2 study testing BFPET in people with Coronary Artery Disease, run by Fluoropharma, Inc. at 1 site in United States.
Trial summary
BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in subjects with known or suspected coronary artery disease (CAD) as compared to standard nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or suspected CAD subjects. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- BFPET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Sep 2019
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must provide written informed consent prior to any study related procedures;
- Subjects must be ≥ 21 and ≤ 85 years of age;
- Subjects must have known or suspected CAD documented by ≥2 segments of reversible perfusion abnormalities on a SPECT (MPI)study
Who cannot join
- Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
- Blood pressure over 180/100mmHg
- Acute changes in comparison to most recent ECG;
- Recent (within 3 months) cardiac arrest, unstable angina, cerebro-vascular accident (CVA), CABG or PCI
- Any pacemaker or defibrillator implanted within the last three months;
- Inability to remain in camera for approximately 60 minutes
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- Bronchospasm
- Serum creatinine > 2 mg/dL;
- Cancer patients who have received chemotherapy or radiation therapy within the past 60 days.
- Any exposure to any investigational drug(s) or medical device(s) within four (4) weeks prior to imaging study;
- Any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination.
- NYHA Class III or IV Congestive heart failure;
- Subject has symptomatic hypotension
- Allergic or intolerant to aminophylline, nitroglycerin or metoprolol
- Allergic or intolerant to regadenoson or any of its excipients
- Prior participants in the study.
- Female subjects only: Positive serum and/or urine pregnancy test or is lactating or the possibility of pregnancy cannot be ruled out prior to dosing.
- Females not of child-bearing potential require confirmatory documentation in their medical records or must have a negative pregnancy test within 4 hours prior to receiving the test drug and agree to use an acceptable form of birth control for at least 30 days following BFPET administration.
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 II Open-Labeled Study to Evaluate BFPET as a Myocardial Perfusion Imaging Agent for the Evaluation of Coronary Artery Disease
BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in subjects with known or suspected coronary artery disease (CAD) as compared to standard nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or suspected CAD subjects.
- Conditions
- Coronary Artery Disease
- Being tested
- BFPET
- Keywords
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFPETDrug
Also called FTPP FluorophenylTriPhenylPhosphonium
Sterile study drug will be delivered in individual dosage vials labeled and calibrated to approximately 2 mCi (74MBq) for the rest imaging and up to 8 mCi (296 MBq) for the stress imaging at the time of injection. The drug will be administered intravenously by bolus injection over 10 seconds into a peripheral vein to which access has been secured followed by saline flush.
| Study group | Role | What they receive |
|---|---|---|
| BFPET | Experimental | BFPET will be administered as a single intravenous injection of up to 2 mCi (74 MBq) at rest and a single intravenous injection of up to 8mCi (296 MBq) following a stress protocol. Total amount not to exceed 10mCi (370 MBq). Receives: Drug: BFPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of BFPET
To evaluate the diagnostic performance of BFPET as a PET agent assessment of myocardial perfusion in known or suspected CAD subjects.
Measured: Up to 30 days
Secondary outcomes (1)
Primary safety endpoints - ECG, physical examinations, vital signs, laboratory and adverse event assessments
Vital signs, ECG, laboratory assessments - up to 24 hours post injection, adverse event assessment at all study visits (7-10 days) post BFPET administration
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study start1 Oct 2018 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fluoropharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georges El Fakhri, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252783
- Sponsor's protocol ID
- BFPET P-02
- Status last verified
- Jul 2018
- First submitted
- 25 Sep 2014
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Labeled Study to Evaluate BFPET as a Myocardial Perfusion Imaging Agent for the Evaluation of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02252783
- Acronym / sponsor ID
- BFPET P-02
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fluoropharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 30 Sep 2014 (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.
BFPET will be evaluated as a diagnostic PET agent for assessing myocardial perfusion in subjects with known or suspected coronary artery disease (CAD) as compared to standard nuclear myocardial perfusion imaging (MPI). The safety of BFPET will be evaluated in known or suspected CAD subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BFPET | Experimental | Drug: BFPETBFPET will be administered as a single intravenous injection of up to 2 mCi (74 MBq) at rest and a single intravenous injection of up to 8mCi (296 MBq) following a stress protocol. Total amount not to exceed 10mCi (370 MBq). |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not 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 ≥ 21 and ≤ 85 years of age;
- Subjects must have known or suspected CAD documented by ≥2 segments of reversible perfusion abnormalities on a SPECT (MPI)study
Key exclusion criteria (18 listed)
- Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
- Blood pressure over 180/100mmHg
- Acute changes in comparison to most recent ECG;
- Recent (within 3 months) cardiac arrest, unstable angina, cerebro-vascular accident (CVA), CABG or PCI
- Any pacemaker or defibrillator implanted within the last three months;
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 |
|---|---|---|
| BFPETAlso: FTPP FluorophenylTriPhenylPhosphoniumSterile study drug will be delivered in individual dosage vials labeled and calibrated to approximately 2 mCi (74MBq) for the rest imaging and up to 8 mCi (296 MBq) for the stress imaging at the time of injection. The drug will be administered intravenously by bolus injection over 10 seconds into a peripheral vein to which access has been secured followed by saline flush. | Drug | BFPET |
Primary outcome
Sensitivity and specificity of BFPET
Time frame: Up to 30 days
To evaluate the diagnostic performance of BFPET as a PET agent assessment of myocardial perfusion in known or suspected CAD subjects.
1 secondary outcome
Primary safety endpoints - ECG, physical examinations, vital signs, laboratory and adverse event assessments
Time frame: Up to 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Georges El Fakhri, Ph.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 2 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 18 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: status not confirmed, as of the sponsor's last update on 1 Aug 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ed Lyons (973-744-1565, ELyons@Fluoropharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of BFPET (time frame: Up to 30 days). 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 1 Aug 2018; AzTrials last refreshed its copy on 31 Oct 2026.