Coronary Artery DiseasePhase 2NCT01778218
A Single Center Study to Establish the Imaging Protocol of 99mTc-EC-DG in Evaluating the Presence and Severity of Coronary Artery Disease (CAD)
A Phase 2 study testing Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose in people with Coronary Artery Disease, run by Cell>Point LLC at 1 site in United States.
Trial summary
This study will assess the safety and tolerability of the investigational radiolabeled imaging agent technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG). Additionally, the study will determine the specific times to best image the heart using a SPECT camera with the investigational imaging agent and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Reversible perfusion defect indicative of CAD on a MIBI exercise/regadenoson study completed within 30 days prior to screening;
- When possible, a coronary angiography will be clinically planned; patient and treating physician must be agreeable to completing the angiogram after the 99mTc-EC-DG exercise/regadenoson study in order for the procedure to be performed.
- The patient is able to provide written informed consent to participate in this study
Who cannot join
- Known cardiomyopathy or history of congestive heart failure (CHF) due to left ventricular systolic dysfunction (ejection fraction < 40%)
- A scheduled coronary angiogram that prevents the 99mTc-EC-DG exercise/regadenoson or rest study visits from being completed prior to the angiogram
- Plans to begin new anti-anginal therapy prior to completing the 99mTc-EC-DG rest/stress study visits
- Contraindication for provocative stress testing based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise or pharmacologic testing
- Intolerance or inability to receive sestamibi or regadenoson, or an inability or unwillingness to exercise on a graded treadmill or receive pharmacologic stress
- Inability to lie still for 30 minutes during image acquisition
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- Women of childbearing potential, unless willing to use adequate contraception throughout the duration of the trial. Adequate contraception is considered hormonal contraception for >3 months prior to entry, intrauterine device (IUD) in place for at least 3 months, double barrier methods (condoms, diaphragm or spermicide), or a partner with non-reversed vasectomy > 40 days prior to entry.
- Pregnant (positive human chorionic gonadotropin [hCG]) pregnancy test at screening for women of childbearing potential) or nursing
- History of malignant disease (excluding treated basal cell or squamous cell carcinoma of skin, or low grade cancers that are stable and do not interfere with exercise which may be allowed with permission from the Medical Monitor) within 5 years prior to screening. Resolution of a prior malignancy more than 5 years prior to screening must be deemed as cured by the Investigator
- Any physical, psychological or substance abuse (drug or alcohol) condition which, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions or may adversely affect the safety of the patient if enrolled in this trial
- A known allergy to 99mTc-EC-DG or its components
- Inability to adhere to requirements specific to the study site's protocols for imaging and exercise/pharmacological stress testing, including but not limited to, dietary restrictions and prohibited medications
- Received an investigational drug within 30 days prior to this study
- Enrolled in or plans to enroll in another clinical trial during this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Imaging Technologies
Kansas City, Kansas, 64111
About this study
Official title: A Single Center Pilot Study to Establish the 99mTc-EC-DG Imaging Protocol to Evaluate the Presence and Severity of Coronary Artery Disease
This study will assess the safety and tolerability of the investigational radiolabeled imaging agent technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG). Additionally, the study will determine the specific times to best image the heart using a SPECT camera with the investigational imaging agent and compare the images to those taken while undergoing the standard rest and exercise/regadenoson testing previously performed to detect the presence and severity of Coronary Artery Disease (CAD).
Read the detailed description
The study will assess the safety and tolerability of technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG).
An outcome will be to develop an imaging protocol for a multicenter trial that will measure the specific imaging parameters required for determination of sensitivity and specificity of 99mTc-EC-DG in a cardiovascular single photon emission computed tomography (SPECT) study compared to an exercise/regadenoson 99mTc- Sestamibi (MIBI) study for detection of the presence and, when available, severity of coronary artery disease (CAD) as documented by coronary angiography when available.
This study will be a single-center, prospective, open-label study of up to 6 patients with positive findings from a MIBI (99mTc-sestamibi) exercise/regadenoson study within 30 days for evaluation of CAD. Patients who meet study eligibility criteria will undergo a 99mTc-EC-DG rest study and a 99mTc-EC-DG exercise/regadenoson study. When possible, patients enrolled will have clinical plans for a coronary angiography study to confirm presence and severity of CAD.
This study will enroll up to 6 patients with a reversible perfusion defect indicative of CAD on a MIBI exercise/regadenoson study. These patients will undergo a 99mTc-EC-DG rest study and an exercise/regadenoson study.
- Conditions
- Coronary Artery Disease
- Being tested
- Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose
- Keywords
- Coronary Artery Disease, CAD
- 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.
Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucoseRadiation
An injection of Technetium ethylenedicysteine-deoxyglucose (99mTc-EC-DG) to yield a target activity of 25 mCi (range of 10-25 mCi) with no more than 250 micrograms of EC-DG to be administered (there must be a minimum of 24 hours between Visit 1 and 2 administrations). Investigational Product to be given by IV push.
| Study group | Role | What they receive |
|---|---|---|
| 99mTc-EC-DG | Experimental | 99mTc-EC-DG injection followed by SPECT imaging during a cardiac rest study (Visit 1) and an exercise/regadenoson study (Visit 2) Receives: Radiation: Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: The number of participants with Adverse Events
Measured: From screening through 7 days after Investigational Product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionMar 2013
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cell>Point LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Bateman, MD, Principal investigator, Cardiovascular Imaging Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778218
- Sponsor's protocol ID
- CP-ECDG-C2
- Status last verified
- Jul 2013
- First submitted
- 22 Jan 2013
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Pilot Study to Establish the 99mTc-EC-DG Imaging Protocol to Evaluate the Presence and Severity of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01778218
- Acronym / sponsor ID
- CP-ECDG-C2
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, CAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cell>Point LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Jan 2013 (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.
This study will assess the safety and tolerability of the investigational radiolabeled imaging agent technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG). Additionally, the study will determine the specific times to best image the heart using a SPECT camera with the investigational imaging agent and compare the images to those taken while undergoing the standard rest and exercise/regadenoson testing previously performed to detect the presence and severity of Coronary Artery Disease (CAD).
Detailed description
The study will assess the safety and tolerability of technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG).
An outcome will be to develop an imaging protocol for a multicenter trial that will measure the specific imaging parameters required for determination of sensitivity and specificity of 99mTc-EC-DG in a cardiovascular single photon emission computed tomography (SPECT) study compared to an exercise/regadenoson 99mTc- Sestamibi (MIBI) study for detection of the presence and, when available, severity of coronary artery disease (CAD) as documented by coronary angiography when available.
This study will be a single-center, prospective, open-label study of up to 6 patients with positive findings from a MIBI (99mTc-sestamibi) exercise/regadenoson study within 30 days for evaluation of CAD. Patients who meet study eligibility criteria will undergo a 99mTc-EC-DG rest study and a 99mTc-EC-DG exercise/regadenoson study. When possible, patients enrolled will have clinical plans for a coronary angiography study to confirm presence and severity of CAD.
This study will enroll up to 6 patients with a reversible perfusion defect indicative of CAD on a MIBI exercise/regadenoson study. These patients will undergo a 99mTc-EC-DG rest study and an exercise/regadenoson study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 99mTc-EC-DG | Experimental | Radiation: Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose99mTc-EC-DG injection followed by SPECT imaging during a cardiac rest study (Visit 1) and an exercise/regadenoson study (Visit 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Reversible perfusion defect indicative of CAD on a MIBI exercise/regadenoson study completed within 30 days prior to screening;
- When possible, a coronary angiography will be clinically planned; patient and treating physician must be agreeable to completing the angiogram after the 99mTc-EC-DG exercise/regadenoson study in order for the procedure to be performed.
- The patient is able to provide written informed consent to participate in this study
Key exclusion criteria (14 listed)
- Known cardiomyopathy or history of congestive heart failure (CHF) due to left ventricular systolic dysfunction (ejection fraction < 40%)
- A scheduled coronary angiogram that prevents the 99mTc-EC-DG exercise/regadenoson or rest study visits from being completed prior to the angiogram
- Plans to begin new anti-anginal therapy prior to completing the 99mTc-EC-DG rest/stress study visits
- Contraindication for provocative stress testing based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise or pharmacologic testing
- Intolerance or inability to receive sestamibi or regadenoson, or an inability or unwillingness to exercise on a graded treadmill or receive pharmacologic stress
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 |
|---|---|---|
| Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucoseAn injection of Technetium ethylenedicysteine-deoxyglucose (99mTc-EC-DG) to yield a target activity of 25 mCi (range of 10-25 mCi) with no more than 250 micrograms of EC-DG to be administered (there must be a minimum of 24 hours between Visit 1 and 2 administrations). Investigational Product to be given by IV push. | Radiation | 99mTc-EC-DG |
Primary outcome
Safety: The number of participants with Adverse Events
Time frame: From screening through 7 days after Investigational Product administration
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 Jul 2013.
- Sponsor LinkLink provided by the sponsor.
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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.
Timothy Bateman, MD principal investigator
Cardiovascular Imaging Technologies
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 Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose in people with Coronary Artery Disease, run by Cell>Point LLC 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 4 inclusion and 14 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 Jul 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 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 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?
Safety: The number of participants with Adverse Events (time frame: From screening through 7 days after Investigational Product administration). 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 Jul 2013.