Heart FailurePhase 2NCT06965621
18F-mFBG Imaging for Myocardial Sympathetic Innervation
A Phase 2 study testing 18F-metaFluorobenzylguanidine and Rubidium-82 in people with Heart Failure and Ischemic Cardiomyopathy, run by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) at 1 site in United States.
Trial summary
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The study will examine a group of stable patients with heart failure (HF) from ischemic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Ischemic Cardiomyopathy, ICD Patients
- What is being tested?
- 18F-metaFluorobenzylguanidine and Rubidium-82
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Stable heart failure from ischemic cardiomyopathy, LVEF < or = 35%, ICD implantation for at least 12 months
Who cannot join
- Unstable coronary artery disease, no ICD implantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Health Houston
Houston, Texas, 77030
K. Lance Gould, MD Principal Investigator, 713-704-2474 ext. Option 3, k.lance.gould@uth.tmc.edu
Patricia Study Coordinator, 713-704-2474, Patricia.M.Mendoza@uth.tmc.edu
About this study
Official title: An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With Heart Failure and Implantable Cardioverter-Defibrillators
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The study will examine a group of stable patients with heart failure (HF) from ischemic cardiomyopathy. All subjects will have left ventricular ejection fraction (LVEF) ≤35% and implantable cardioverter-defibrillators (ICD). The primary objectives of the study will be to:
- document the degree to which 18F-mFBG uptake in the heart is reduced (compared to historical controls)
- characterize the distribution of regional abnormalities in relation to findings on rest/stress positron-emission tomography (PET) myocardial perfusion imaging (MPI)
- determine if there are global and/or regional differences in myocardial sympathetic innervation between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months Effectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).
Safety data will be collected to identify adverse events [AEs] and serious adverse events [SAEs] and characterize the safety profile of 18F-mFBG.
Read the detailed description
The focus of most research into myocardial sympathetic neuronal imaging has been on NE analogues labeled with gamma- or positron-emitting radioisotopes. The most widely studied conventional nuclear imaging agent is 123I-metaiodobenzylguanidine (123I-mIBG), which provides effective and well-validated semi-quantitative information. In the pivotal trial (ADMIRE-HF) on which the US approval of 123I-mIBG for cardiac imaging was based, there was an increased occurrence of adverse outcomes (composite of HF progression, potentially fatal arrhythmias, and cardiac death) in HF subjects based upon the heart/mediastinum (H/M) ratio on late ("delayed") planar 123I-mIBG (AdreView™) images. Analyses of all-cause mortality in the ADMIRE-HFX extension study confirmed the low risk associated with H/M ≥1.60 (2-year mortality of 4%). Subsequent analyses specifically focused on arrhythmic events suggested that sympathetic neuronal imaging could aid in discriminating between low and higher risk cohorts. However, 123I-mIBG imaging results are heavily dependent on the imaging equipment and acquisition techniques used, and global standardization efforts have had limited success. In addition, absolute quantitation of myocardial uptake and clearance kinetics cannot be effectively achieved using single-photon emission computed tomography (SPECT), even with use of attenuation and scatter correction methods. These limitations and the high cost of the procedure have severely limited its use in clinical practice.
The preferred nuclear technique for high-resolution quantitative imaging of cellular functional behavior is PET. The present research will utilize a new 18F-labeled radiopharmaceutical, 18F-meta-fluorobenzylguanidine (18F-mFBG). The greatest advantage of this agent is its structural equivalence to 123I-mIBG, with the 123I atom in the latter replaced by a 18F atom.
The vast clinical and research experience with mIBG provides a strong basis for the expected performance of 18F-mFBG. In addition, animal and limited human experience suggests that clearance of 18F-mFBG from blood and certain target organs is more rapid than mIBG, such that target-background ratios (TBRs) for the heart should be superior for 18F-mFBG, improving both image quality and reliability of global and regional myocardial quantitation. To date, the focus of most research using 18F-mFBG has been on its use as an imaging agent for neural crest tumors such as neuroblastoma and pheochromocytoma (22). However, analyses of myocardial 18F-mFBG uptake in patients being evaluated for neural crest tumors suggested this agent could be effective as a cardiac imaging agent.
Past analyses of cardiac sympathetic imaging results have suggested this method might be of value for identifying heart disease patients at greater risk for arrhythmic events and sudden cardiac arrest (SCA). The largest prospective study on this topic enrolled 204 subjects eligible for implantable cardioverter defibrillators (LVEF ≤35%) who underwent cardiac PET imaging for myocardial sympathetic denervation using 11C-meta-hydroxyephedrine (11C-HED). The results showed that volume of denervated myocardium had the strongest correlation with SCA (arrhythmic death or defibrillator discharge). The 33 subjects with SCA had significantly larger denervated volumes than the 171 subjects without SCA (33±10% vs 26±11%; p<0.001). Multivariate analysis revealed that presence of 2 or more of risk factors of sympathetic denervation >37.6% of LV, LV end-diastolic index >99 ml/M2, creatinine >1.49 mg/dl, and no anti-angiotensin medication predicted a nearly 50% event rate over 4 years vs <1% annual rate without these risk factors (p < 0.0001).
The rationale for the present study is twofold.
- Correlate areas of cardiac denervation with accurate measurements of regional cardiac blood flow (CBF) and inducible ischemia using standardized 82Rb PET.
- Determine variables of sympathetic innervation and CBF most strongly related to past occurrence of arrhythmic events.
With the greater sensitivity and resolution of PET imaging compared to planar and SPECT techniques, it is expected that 18F -mFBG imaging will detect abnormalities that are missed with 123I mIBG and provide the reliable and reproducible quantitative accuracy necessary to support use of this agent for clinical patient studies.
- Conditions
- Heart Failure, Ischemic Cardiomyopathy, ICD Patients
- Being tested
- 18F-metaFluorobenzylguanidine, Rubidium-82
- Keywords
- Myocardial sympathetic innervation, PET myocardial imaging, 18F-mFBG
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-metaFluorobenzylguanidineDrug
Also called IRP101
PET Radiopharmaceutical to assess myocardial sympathetic innervation
Rubidium-82Drug
PET Radiopharmaceutical to assess myocardial perfusion
| Study group | Role | What they receive |
|---|---|---|
| Ischemic cardiomyopathy with ICD discharge | Active comparator | 82Rb and 18F-mFBG will be administered to intraveously to 10 heart failure patients with ischemic cardiomyopathy and an ICD discharge within the past 12 months Receives: Drug: 18F-metaFluorobenzylguanidine; Drug: Rubidium-82 |
| Ischemic cardiomyopathy without ICD discharge | Active comparator | 82Rb and 18F-mFBG will be administered intravenously to 10 heart failure patients with ischemic cardiomyopathy and no ICD discharge within the past 12 months Receives: Drug: 18F-metaFluorobenzylguanidine; Drug: Rubidium-82 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify the degree of reduced myocardial 18F-mFBG uptake in adult HF subjects with well-characterized coronary heart disease
Obtain computer quantification of global and/or regional differences in myocardial sympathetic innervation (based on 18F-mFBG uptake) between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months
Measured: 24 hours from administration of the study drug for PET imaging and safety follow-up
Secondary outcomes (2)
Quanify regional patterns of 18F-mFBG myocardial uptake and distribution
Obtain comparative computer quantification of regional patterns of 18F-mFBG myocardial uptake (sympathetic innervation) and areas of abnormal myocardial perfusion (blood flow) and/or wall motion (myocardial contraction) on PET myocardial perfusion imaging with Rubidium-82.
Measured: 24 hours from administration of the study drug for PET imaging and safety follow-up
Perform Safety Data Collection for 18F-mFBG
Collect scheduled safety assessment data for 18F-mFBG Serious Adverse Events (SAE's) and Adverse Events (AE's).
Measured: 24 hours from administration of the study drug for safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start5 Nov 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas
- Responsible party
- Sponsor
- Investigators
- K. Lance Gould, MD, Principal investigator, Professor of Medicine, McGovern Medical School, UTHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965621
- Sponsor's protocol ID
- IRP101-221
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small Phase 2 study of an investigational drug; subject information will be available to the investigators and study sponsor only.
Publications
Nakajima K, Verschure DO, Okuda K, Verberne HJ. Standardization of 123I-meta-iodobenzylguanidine myocardial sympathetic activity imaging: phantom calibration and clinical applications. Clin Transl Imaging. 2017;5(3):255-263. doi: 10.1007/s40336-017-0230-2. Epub 2017 May 4.
PubMed 28596948Verschure DO, Poel E, Travin MI, Henzlova MJ, Jain D, Jacobson AF, Verberne HJ. A simplified wall-based model for regional innervation/perfusion mismatch assessed by cardiac 123I-mIBG and rest 99mTc-tetrofosmin SPECT to predict arrhythmic events in ischaemic heart failure. Eur Heart J Cardiovasc Imaging. 2022 Aug 22;23(9):1201-1209. doi: 10.1093/ehjci/jeab132.
PubMed 34427293Travin MI, Henzlova MJ, van Eck-Smit BLF, Jain D, Carrio I, Folks RD, Garcia EV, Jacobson AF, Verberne HJ. Assessment of 123I-mIBG and 99mTc-tetrofosmin single-photon emission computed tomographic images for the prediction of arrhythmic events in patients with ischemic heart failure: Intermediate severity innervation defects are associated with higher arrhythmic risk. J Nucl Cardiol. 2017 Apr;24(2):377-391. doi: 10.1007/s12350-015-0336-8. Epub 2016 Jan 20.
PubMed 26791866Sood N, Al Badarin F, Parker M, Pullatt R, Jacobson AF, Bateman TM, Heller GV. Resting perfusion MPI-SPECT combined with cardiac 123I-mIBG sympathetic innervation imaging improves prediction of arrhythmic events in non-ischemic cardiomyopathy patients: sub-study from the ADMIRE-HF trial. J Nucl Cardiol. 2013 Oct;20(5):813-20. doi: 10.1007/s12350-013-9750-y. Epub 2013 Jul 18.
PubMed 23864400Narula J, Gerson M, Thomas GS, Cerqueira MD, Jacobson AF. (1)(2)(3)I-MIBG Imaging for Prediction of Mortality and Potentially Fatal Events in Heart Failure: The ADMIRE-HFX Study. J Nucl Med. 2015 Jul;56(7):1011-8. doi: 10.2967/jnumed.115.156406. Epub 2015 Jun 11.
PubMed 26069309Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, Agostini D, Weiland F, Chandna H, Narula J; ADMIRE-HF Investigators. Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. J Am Coll Cardiol. 2010 May 18;55(20):2212-21. doi: 10.1016/j.jacc.2010.01.014. Epub 2010 Feb 25.
PubMed 20188504
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With Heart Failure and Implantable Cardioverter-Defibrillators
- ClinicalTrials.gov ID
- NCT06965621
- Acronym / sponsor ID
- IRP101-221
- Conditions
- Heart Failure, Ischemic Cardiomyopathy, ICD Patients
- Keywords
- Myocardial sympathetic innervation, PET myocardial imaging, 18F-mFBG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)Industry (pharma, biotech, devices)
- Collaborators
- University of Texas
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- 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 is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The study will examine a group of stable patients with heart failure (HF) from ischemic cardiomyopathy. All subjects will have left ventricular ejection fraction (LVEF) ≤35% and implantable cardioverter-defibrillators (ICD). The primary objectives of the study will be to:
- document the degree to which 18F-mFBG uptake in the heart is reduced (compared to historical controls)
- characterize the distribution of regional abnormalities in relation to findings on rest/stress positron-emission tomography (PET) myocardial perfusion imaging (MPI)
- determine if there are global and/or regional differences in myocardial sympathetic innervation between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months Effectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).
Safety data will be collected to identify adverse events [AEs] and serious adverse events [SAEs] and characterize the safety profile of 18F-mFBG.
Detailed description
The focus of most research into myocardial sympathetic neuronal imaging has been on NE analogues labeled with gamma- or positron-emitting radioisotopes. The most widely studied conventional nuclear imaging agent is 123I-metaiodobenzylguanidine (123I-mIBG), which provides effective and well-validated semi-quantitative information. In the pivotal trial (ADMIRE-HF) on which the US approval of 123I-mIBG for cardiac imaging was based, there was an increased occurrence of adverse outcomes (composite of HF progression, potentially fatal arrhythmias, and cardiac death) in HF subjects based upon the heart/mediastinum (H/M) ratio on late ("delayed") planar 123I-mIBG (AdreView™) images. Analyses of all-cause mortality in the ADMIRE-HFX extension study confirmed the low risk associated with H/M ≥1.60 (2-year mortality of 4%). Subsequent analyses specifically focused on arrhythmic events suggested that sympathetic neuronal imaging could aid in discriminating between low and higher risk cohorts. However, 123I-mIBG imaging results are heavily dependent on the imaging equipment and acquisition techniques used, and global standardization efforts have had limited success. In addition, absolute quantitation of myocardial uptake and clearance kinetics cannot be effectively achieved using single-photon emission computed tomography (SPECT), even with use of attenuation and scatter correction methods. These limitations and the high cost of the procedure have severely limited its use in clinical practice.
The preferred nuclear technique for high-resolution quantitative imaging of cellular functional behavior is PET. The present research will utilize a new 18F-labeled radiopharmaceutical, 18F-meta-fluorobenzylguanidine (18F-mFBG). The greatest advantage of this agent is its structural equivalence to 123I-mIBG, with the 123I atom in the latter replaced by a 18F atom.
The vast clinical and research experience with mIBG provides a strong basis for the expected performance of 18F-mFBG. In addition, animal and limited human experience suggests that clearance of 18F-mFBG from blood and certain target organs is more rapid than mIBG, such that target-background ratios (TBRs) for the heart should be superior for 18F-mFBG, improving both image quality and reliability of global and regional myocardial quantitation. To date, the focus of most research using 18F-mFBG has been on its use as an imaging agent for neural crest tumors such as neuroblastoma and pheochromocytoma (22). However, analyses of myocardial 18F-mFBG uptake in patients being evaluated for neural crest tumors suggested this agent could be effective as a cardiac imaging agent.
Past analyses of cardiac sympathetic imaging results have suggested this method might be of value for identifying heart disease patients at greater risk for arrhythmic events and sudden cardiac arrest (SCA). The largest prospective study on this topic enrolled 204 subjects eligible for implantable cardioverter defibrillators (LVEF ≤35%) who underwent cardiac PET imaging for myocardial sympathetic denervation using 11C-meta-hydroxyephedrine (11C-HED). The results showed that volume of denervated myocardium had the strongest correlation with SCA (arrhythmic death or defibrillator discharge). The 33 subjects with SCA had significantly larger denervated volumes than the 171 subjects without SCA (33±10% vs 26±11%; p<0.001). Multivariate analysis revealed that presence of 2 or more of risk factors of sympathetic denervation >37.6% of LV, LV end-diastolic index >99 ml/M2, creatinine >1.49 mg/dl, and no anti-angiotensin medication predicted a nearly 50% event rate over 4 years vs <1% annual rate without these risk factors (p < 0.0001).
The rationale for the present study is twofold.
- Correlate areas of cardiac denervation with accurate measurements of regional cardiac blood flow (CBF) and inducible ischemia using standardized 82Rb PET.
- Determine variables of sympathetic innervation and CBF most strongly related to past occurrence of arrhythmic events.
With the greater sensitivity and resolution of PET imaging compared to planar and SPECT techniques, it is expected that 18F -mFBG imaging will detect abnormalities that are missed with 123I mIBG and provide the reliable and reproducible quantitative accuracy necessary to support use of this agent for clinical patient studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic cardiomyopathy with ICD discharge | Active comparator | Drug: 18F-metaFluorobenzylguanidine, Drug: Rubidium-8282Rb and 18F-mFBG will be administered to intraveously to 10 heart failure patients with ischemic cardiomyopathy and an ICD discharge within the past 12 months |
| Ischemic cardiomyopathy without ICD discharge | Active comparator | Drug: 18F-metaFluorobenzylguanidine, Drug: Rubidium-8282Rb and 18F-mFBG will be administered intravenously to 10 heart failure patients with ischemic cardiomyopathy and no ICD discharge within the past 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stable heart failure from ischemic cardiomyopathy, LVEF < or = 35%, ICD implantation for at least 12 months
Key exclusion criteria (1 listed)
- Unstable coronary artery disease, no ICD implantation
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 |
|---|---|---|
| 18F-metaFluorobenzylguanidineAlso: IRP101PET Radiopharmaceutical to assess myocardial sympathetic innervation | Drug | Ischemic cardiomyopathy with ICD discharge, Ischemic cardiomyopathy without ICD discharge |
| Rubidium-82PET Radiopharmaceutical to assess myocardial perfusion | Drug | Ischemic cardiomyopathy with ICD discharge, Ischemic cardiomyopathy without ICD discharge |
Primary outcome
Quantify the degree of reduced myocardial 18F-mFBG uptake in adult HF subjects with well-characterized coronary heart disease
Time frame: 24 hours from administration of the study drug for PET imaging and safety follow-up
Obtain computer quantification of global and/or regional differences in myocardial sympathetic innervation (based on 18F-mFBG uptake) between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months
2 secondary outcomes
Quanify regional patterns of 18F-mFBG myocardial uptake and distribution
Time frame: 24 hours from administration of the study drug for PET imaging and safety follow-up
Perform Safety Data Collection for 18F-mFBG
Time frame: 24 hours from administration of the study drug for safety follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 28596948Nakajima K, Verschure DO, Okuda K, Verberne HJ. Standardization of 123I-meta-iodobenzylguanidine myocardial sympathetic activity imaging: phantom calibration and clinical applications. Clin Transl Imaging. 2017;5(3):255-263. doi: 10.1007/s40336-017-0230-2. Epub 2017 May 4.
- Background: PubMed 34427293Verschure DO, Poel E, Travin MI, Henzlova MJ, Jain D, Jacobson AF, Verberne HJ. A simplified wall-based model for regional innervation/perfusion mismatch assessed by cardiac 123I-mIBG and rest 99mTc-tetrofosmin SPECT to predict arrhythmic events in ischaemic heart failure. Eur Heart J Cardiovasc Imaging. 2022 Aug 22;23(9):1201-1209. doi: 10.1093/ehjci/jeab132.
- Background: PubMed 26791866Travin MI, Henzlova MJ, van Eck-Smit BLF, Jain D, Carrio I, Folks RD, Garcia EV, Jacobson AF, Verberne HJ. Assessment of 123I-mIBG and 99mTc-tetrofosmin single-photon emission computed tomographic images for the prediction of arrhythmic events in patients with ischemic heart failure: Intermediate severity innervation defects are associated with higher arrhythmic risk. J Nucl Cardiol. 2017 Apr;24(2):377-391. doi: 10.1007/s12350-015-0336-8. Epub 2016 Jan 20.
- Background: PubMed 23864400Sood N, Al Badarin F, Parker M, Pullatt R, Jacobson AF, Bateman TM, Heller GV. Resting perfusion MPI-SPECT combined with cardiac 123I-mIBG sympathetic innervation imaging improves prediction of arrhythmic events in non-ischemic cardiomyopathy patients: sub-study from the ADMIRE-HF trial. J Nucl Cardiol. 2013 Oct;20(5):813-20. doi: 10.1007/s12350-013-9750-y. Epub 2013 Jul 18.
- Background: PubMed 26069309Narula J, Gerson M, Thomas GS, Cerqueira MD, Jacobson AF. (1)(2)(3)I-MIBG Imaging for Prediction of Mortality and Potentially Fatal Events in Heart Failure: The ADMIRE-HFX Study. J Nucl Med. 2015 Jul;56(7):1011-8. doi: 10.2967/jnumed.115.156406. Epub 2015 Jun 11.
- Background: PubMed 20188504Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, Agostini D, Weiland F, Chandna H, Narula J; ADMIRE-HF Investigators. Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. J Am Coll Cardiol. 2010 May 18;55(20):2212-21. doi: 10.1016/j.jacc.2010.01.014. Epub 2010 Feb 25.
- Individual participant dataSharing planned: No. This is a small Phase 2 study of an investigational drug; subject information will be available to the investigators and study sponsor only.
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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.
K. Lance Gould, MD principal investigator
Professor of Medicine, McGovern Medical School, UTHealth
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 18F-metaFluorobenzylguanidine and Rubidium-82 in people with Heart Failure and Ischemic Cardiomyopathy, run by Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact K. Lance Gould, MD (713-704-2489, K.Lance.Gould@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify the degree of reduced myocardial 18F-mFBG uptake in adult HF subjects with well-characterized coronary heart disease (time frame: 24 hours from administration of the study drug for PET imaging and safety follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06965621, which also lists 6 linked publications.
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 Jul 2026.