Cardiac AmyloidosisPhase 3NCT05619302
Molecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis
A Phase 3 study testing [68Ga]CBP8 PET/MRI in people with Cardiac Amyloidosis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The primary aim of our pilot study is to determine whether fibrosis in the heart can be measured with [68Ga]CBP8, a positron emission tomography (PET) probe, using PET/magnetic resonance imaging (MRI) imaging, in 30 individuals with documented cardiac amyloidosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Amyloidosis
- What is being tested?
- [68Ga]CBP8 PET/MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 31 Dec 2026
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Willing and able to provide consent
- AL-CA: Diagnosis of systemic light chain amyloidosis by standard criteria: Immunofixation of serum, serum free light chain (FLC) assay, a biopsy of fat pad/bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by mass spectroscopy as needed AND
- Proof of cardiac involvement by AL amyloidosis
- Abnormal cardiac biomarkers: abnormal high sensitivity TnT 5th generation levels (> 15 ng/L) or abnormal age-appropriate NT-proBNP (abnormal values: < 50 years: > 450 pg/ml; 50-75 years: > 900 pg/ml; > 75 years: > 1800 pg/ml) OR
- Abnormal echocardiogram (wall thickness > 12 mm in the absence of other causes of increased LV wall thickness) OR
Show all 28Show fewer
- Abnormal CMR (wall thickness > 12 mm, extracellular volume > 0.40 or typical CMR appearance of cardiac amyloidosis with difficulty nulling images and non-coronary distribution late gadolinium enhancement) OR
- Positive endomyocardial biopsy
- Age > 18 years
- Willing and able to provide consent
- ATTR-CA: Diagnosis of either wildtype or hereditary transthyretin cardiac amyloidosis by standard criteria: Endomyocardial biopsy followed by typing of the transthyretin amyloidosis using immunohistochemistry or immunogold assay with confirmation by mass spectroscopy as needed
- Extracardiac biopsy with typical cardiac imaging findings
- Hereditary ATTR amyloidosis by genetic testing OR
- Grade 2 or grade 3 myocardial uptake of 99mTc-PYP if AL amyloidosis is excluded
- Inclusion Criteria for recent myocardial infarction subjects:
- Age > 18 years
- Willing and able to provide consent
- Recent MI: Diagnosis of recent type 1 myocardial infarction by standard criteria
- More than 6 weeks from diagnosis of MI but within 6 months
- Imaging evidence of loss of viable myocardium or persistent regional wall motion abnormalities in a pattern consistent with an ischemic etiology in more than one segment
- Inclusion Criteria for hypertrophic cardiomyopathy subjects:
- Age > 18 years
- Willing and able to provide consent
- Hypertrophic cardiomyopathy: Diagnosis of hypertrophic cardiomyopathy by standard criteria
- MRI evidence of late gadolinium enhancement
- Age > 18 years
- Willing and able to provide consent
- No known cardiac amyloidosis or recent myocardial infarction
Who cannot join
- Dialysis
- NYHA (New York Heart Association) Class IV
- Acute myocardial infarction within 6 weeks
- Pregnancy or nursing
- History of adverse events from or allergy to gadolinium contrast media
- Hemodynamic instability
Show all 12Show fewer
- Severe claustrophobia despite use of sedatives
- Decompensated heart failure (unable to lie flat for 1 hour)
- Concomitant clinically significant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)
- Body weight over limit for MRI table (>300 lbs)
- Contraindications for MRI (including non-compatible cardiac implantable electronic devices, drug infusion pumps, and metallic or electric implants)
- Any other reason determined by the investigator to be unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The primary aim of our pilot study is to determine whether fibrosis in the heart can be measured with [68Ga]CBP8, a positron emission tomography (PET) probe, using PET/magnetic resonance imaging (MRI) imaging, in 30 individuals with documented cardiac amyloidosis. The investigators will also enroll 15 individuals with recent myocardial infarction and 15 individuals with hypertrophic cardiomyopathy as positive controls for fibrosis, and the investigators will enroll 5 individuals without cardiovascular disease to undergo [68Ga]CBP8 PET/MRI imaging as a healthy control group.
The primary hypothesis of this study is that [68Ga]CBP8 will bind to interstitial collagen and quantify myocardial fibrosis in patients with cardiac amyloidosis. The investigators hypothesize that [68Ga]CBP8 uptake will be greater in patients with cardiac amyloidosis, myocardial fibrosis, and hypertrophic cardiomyopathy than in healthy controls. Secondly, the investigators also hypothesize that [68Ga]CBP8 activity more strongly correlates with standard MRI measures in patients with recent myocardial infarction and hypertrophic cardiomyopathy (where extracellular expansion is caused by myocardial fibrosis/collagen deposition) than in patients with cardiac amyloidosis (where myocardial fibrosis is combined with infiltration).
Read the detailed description
[68Ga]CBP8 is a novel gallium-68 labeled positron emission tomography (PET) probe that selectively binds collagen type I, which constitutes the majority of fibrotic tissue. In pre-clinical mouse models, [68Ga]CBP8 had the sensitivity to detect pulmonary fibrosis even at early stages and specificity for collagen uptake with low non-specific uptake in background tissues and organs. In preliminary studies in humans with idiopathic pulmonary fibrosis, patients tolerated [68Ga]CBP8 without adverse effects, and there was a strong correspondence between high collagen tracer signal and fibrotic lung regions established by chest computed tomography (CT) scan. [68Ga]CBP8 may be a valuable tool to detect and quantify collagen in the heart. The investigators propose to test [68Ga]CBP8 in a pilot study to image myocardial fibrosis in patients with cardiac amyloidosis.
Cardiac amyloidosis is characterized by myocardial interstitial infiltration by misfolded amyloid fibrils. Infiltration leads to increased myocardial stiffness and heart failure. In patients with cardiac amyloidosis, myocardial stiffness may also be caused by extracellular collagen deposition in the myocardium. Collagen deposition (i.e. myocardial fibrosis) results in adverse cardiac remodeling through similar mechanisms as amyloidosis and may potentiate heart failure in patients with cardiac amyloidosis. Myocardial fibrosis can be mitigated or prevented. In addition, therapies directed against amyloid fibrils also have differential response rates in cardiac amyloidosis patients with or without coexistent fibrosis. Magnetic resonance imaging (MRI) is an established method of measuring extracellular volume (ECV), a reliable way of quantifying myocardial fibrosis in conditions where the primary reason for ECV expansion is myocardial fibrosis. ECV may not be an optimal surrogate of myocardial fibrosis in patients with cardiac amyloidosis, where ECV is already quite expanded due to myocardial amyloid infiltration. Thus, a means of accurate, non-invasive quantitation of myocardial fibrosis has the potential to significantly improve cardiac amyloidosis care.
This pilot study is designed to understand whether myocardial fibrosis can be measured using a collagen 1 targeted radiotracer ([68Ga]CBP8). The investigators would like to study 15 patients with light-chain (AL) cardiac amyloidosis and 15 patients with transthyretin (ATTR) cardiac amyloidosis to understand differences in radiotracer uptake, if any. The investigators will also enroll 15 patients with recent myocardial infarction and 15 patients with hypertrophic cardiomyopathy as positive controls for fibrosis and will enroll 5 individuals without cardiovascular disease as negative controls.
The aim of this proposed research study is, using simultaneous PET/MRI imaging, to determine whether [68Ga]CBP8 uptake will accurately identify and quantify myocardial fibrosis in patients with cardiac amyloidosis, recent myocardial infarction, and hypertrophic cardiomyopathy. The aim of this study is also to correlate [68Ga]CBP8 PET uptake with standard MRI measures in patients with cardiac amyloidosis.
- Conditions
- Cardiac Amyloidosis
- Being tested
- [68Ga]CBP8 PET/MRI
- Keywords
- Amyloidosis, Cardiac, Heart, Imaging, Diagnosis
- Medical subject headings
- Amyloid Neuropathies, Familial, Amyloidosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]CBP8 PET/MRIDrug
Also called No other names
Simultaneous cardiac PET/MRI images will be obtained following injection of [68Ga]CBP8
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]CBP8 PET/MRI Amyloid Subjects | Experimental | Individuals with documented cardiac amyloidosis will undergo [68Ga]CBP8 PET/MRI. Receives: Drug: [68Ga]CBP8 PET/MRI |
| [68Ga]CBP8 PET/MRI Recent Myocardial Infarction Subjects | Active comparator | Individuals with recent myocardial infarction will undergo [68Ga]CBP8 PET/MRI. Receives: Drug: [68Ga]CBP8 PET/MRI |
| [68Ga]CBP8 PET/MRI Healthy Controls | Placebo comparator | Individuals without documented cardiovascular disease will undergo [68Ga]CBP8 PET/MRI. Receives: Drug: [68Ga]CBP8 PET/MRI |
| [68Ga]CBP8 PET/MRI Hypertrophic Cardiomyopathy Subjects | Active comparator | Individuals with hypertrophic cardiomyopathy will undergo [68Ga]CBP8 PET/MRI. Receives: Drug: [68Ga]CBP8 PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Standardized Uptake Value (SUVmean) of [68Ga]CBP8 uptake in the heart
Standardized uptake value (SUV) mean is defined as the mean [68Ga]CBP8 concentration measured within the left ventricular myocardium multiplied by the decay-corrected amount of injected [68Ga]CBP8 normalized to patient weight. We expect SUVmean will be greater in patients with cardiac amyloidosis and myocardial infarction compared with healthy control subjects.
Measured: 1 day
Extracellular volume from clinically performed simultaneous cardiac MRI
We will correlate [68Ga]CBP8 uptake with standard MRI extracellular volume (ECV) measures. We expect [68Ga]CBP8 activity to more strongly correlate with MRI in patients with myocardial infarction than cardiac amyloidosis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start3 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharmila Dorbala, Brigham and Women's Hospital
- Investigators
- Sharmila Dorbala, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619302
- Sponsor's protocol ID
- 2022A012856
- Status last verified
- Jul 2026
- First submitted
- 9 Nov 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available.
PubMed 31161770Desogere P, Tapias LF, Rietz TA, Rotile N, Blasi F, Day H, Elliott J, Fuchs BC, Lanuti M, Caravan P. Optimization of a Collagen-Targeted PET Probe for Molecular Imaging of Pulmonary Fibrosis. J Nucl Med. 2017 Dec;58(12):1991-1996. doi: 10.2967/jnumed.117.193532. Epub 2017 Jun 13.
PubMed 28611243Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696.
PubMed 28381537
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis
- ClinicalTrials.gov ID
- NCT05619302
- Acronym / sponsor ID
- 2022A012856
- Conditions
- Cardiac Amyloidosis
- Keywords
- Amyloidosis, Cardiac, Heart, Imaging, Diagnosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Nov 2022 (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.
The primary aim of our pilot study is to determine whether fibrosis in the heart can be measured with [68Ga]CBP8, a positron emission tomography (PET) probe, using PET/magnetic resonance imaging (MRI) imaging, in 30 individuals with documented cardiac amyloidosis. The investigators will also enroll 15 individuals with recent myocardial infarction and 15 individuals with hypertrophic cardiomyopathy as positive controls for fibrosis, and the investigators will enroll 5 individuals without cardiovascular disease to undergo [68Ga]CBP8 PET/MRI imaging as a healthy control group.
The primary hypothesis of this study is that [68Ga]CBP8 will bind to interstitial collagen and quantify myocardial fibrosis in patients with cardiac amyloidosis. The investigators hypothesize that [68Ga]CBP8 uptake will be greater in patients with cardiac amyloidosis, myocardial fibrosis, and hypertrophic cardiomyopathy than in healthy controls. Secondly, the investigators also hypothesize that [68Ga]CBP8 activity more strongly correlates with standard MRI measures in patients with recent myocardial infarction and hypertrophic cardiomyopathy (where extracellular expansion is caused by myocardial fibrosis/collagen deposition) than in patients with cardiac amyloidosis (where myocardial fibrosis is combined with infiltration).
Detailed description
[68Ga]CBP8 is a novel gallium-68 labeled positron emission tomography (PET) probe that selectively binds collagen type I, which constitutes the majority of fibrotic tissue. In pre-clinical mouse models, [68Ga]CBP8 had the sensitivity to detect pulmonary fibrosis even at early stages and specificity for collagen uptake with low non-specific uptake in background tissues and organs. In preliminary studies in humans with idiopathic pulmonary fibrosis, patients tolerated [68Ga]CBP8 without adverse effects, and there was a strong correspondence between high collagen tracer signal and fibrotic lung regions established by chest computed tomography (CT) scan. [68Ga]CBP8 may be a valuable tool to detect and quantify collagen in the heart. The investigators propose to test [68Ga]CBP8 in a pilot study to image myocardial fibrosis in patients with cardiac amyloidosis.
Cardiac amyloidosis is characterized by myocardial interstitial infiltration by misfolded amyloid fibrils. Infiltration leads to increased myocardial stiffness and heart failure. In patients with cardiac amyloidosis, myocardial stiffness may also be caused by extracellular collagen deposition in the myocardium. Collagen deposition (i.e. myocardial fibrosis) results in adverse cardiac remodeling through similar mechanisms as amyloidosis and may potentiate heart failure in patients with cardiac amyloidosis. Myocardial fibrosis can be mitigated or prevented. In addition, therapies directed against amyloid fibrils also have differential response rates in cardiac amyloidosis patients with or without coexistent fibrosis. Magnetic resonance imaging (MRI) is an established method of measuring extracellular volume (ECV), a reliable way of quantifying myocardial fibrosis in conditions where the primary reason for ECV expansion is myocardial fibrosis. ECV may not be an optimal surrogate of myocardial fibrosis in patients with cardiac amyloidosis, where ECV is already quite expanded due to myocardial amyloid infiltration. Thus, a means of accurate, non-invasive quantitation of myocardial fibrosis has the potential to significantly improve cardiac amyloidosis care.
This pilot study is designed to understand whether myocardial fibrosis can be measured using a collagen 1 targeted radiotracer ([68Ga]CBP8). The investigators would like to study 15 patients with light-chain (AL) cardiac amyloidosis and 15 patients with transthyretin (ATTR) cardiac amyloidosis to understand differences in radiotracer uptake, if any. The investigators will also enroll 15 patients with recent myocardial infarction and 15 patients with hypertrophic cardiomyopathy as positive controls for fibrosis and will enroll 5 individuals without cardiovascular disease as negative controls.
The aim of this proposed research study is, using simultaneous PET/MRI imaging, to determine whether [68Ga]CBP8 uptake will accurately identify and quantify myocardial fibrosis in patients with cardiac amyloidosis, recent myocardial infarction, and hypertrophic cardiomyopathy. The aim of this study is also to correlate [68Ga]CBP8 PET uptake with standard MRI measures in patients with cardiac amyloidosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| [68Ga]CBP8 PET/MRI Amyloid Subjects | Experimental | Drug: [68Ga]CBP8 PET/MRIIndividuals with documented cardiac amyloidosis will undergo [68Ga]CBP8 PET/MRI. |
| [68Ga]CBP8 PET/MRI Recent Myocardial Infarction Subjects | Active comparator | Drug: [68Ga]CBP8 PET/MRIIndividuals with recent myocardial infarction will undergo [68Ga]CBP8 PET/MRI. |
| [68Ga]CBP8 PET/MRI Healthy Controls | Placebo comparator | Drug: [68Ga]CBP8 PET/MRIIndividuals without documented cardiovascular disease will undergo [68Ga]CBP8 PET/MRI. |
| [68Ga]CBP8 PET/MRI Hypertrophic Cardiomyopathy Subjects | Active comparator | Drug: [68Ga]CBP8 PET/MRIIndividuals with hypertrophic cardiomyopathy will undergo [68Ga]CBP8 PET/MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Age > 18 years
- Willing and able to provide consent
- AL-CA: Diagnosis of systemic light chain amyloidosis by standard criteria: Immunofixation of serum, serum free light chain (FLC) assay, a biopsy of fat pad/bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by mass spectroscopy as needed AND
- Age > 18 years
- Willing and able to provide consent
Key exclusion criteria (12 listed)
- Dialysis
- NYHA (New York Heart Association) Class IV
- Acute myocardial infarction within 6 weeks
- Pregnancy or nursing
- History of adverse events from or allergy to gadolinium contrast media
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 |
|---|---|---|
| [68Ga]CBP8 PET/MRIAlso: No other namesSimultaneous cardiac PET/MRI images will be obtained following injection of [68Ga]CBP8 | Drug | [68Ga]CBP8 PET/MRI Amyloid Subjects, [68Ga]CBP8 PET/MRI Healthy Controls, [68Ga]CBP8 PET/MRI Hypertrophic Cardiomyopathy Subjects, [68Ga]CBP8 PET/MRI Recent Myocardial Infarction Subjects |
Primary outcome
Mean Standardized Uptake Value (SUVmean) of [68Ga]CBP8 uptake in the heart
Time frame: 1 day
Standardized uptake value (SUV) mean is defined as the mean [68Ga]CBP8 concentration measured within the left ventricular myocardium multiplied by the decay-corrected amount of injected [68Ga]CBP8 normalized to patient weight. We expect SUVmean will be greater in patients with cardiac amyloidosis and myocardial infarction compared with healthy control subjects.
Extracellular volume from clinically performed simultaneous cardiac MRI
Time frame: 1 day
We will correlate [68Ga]CBP8 uptake with standard MRI extracellular volume (ECV) measures. We expect [68Ga]CBP8 activity to more strongly correlate with MRI in patients with myocardial infarction than cardiac amyloidosis.
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 6 Jul 2026.
- Background: PubMed 31161770Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available.
- Background: PubMed 28611243Desogere P, Tapias LF, Rietz TA, Rotile N, Blasi F, Day H, Elliott J, Fuchs BC, Lanuti M, Caravan P. Optimization of a Collagen-Targeted PET Probe for Molecular Imaging of Pulmonary Fibrosis. J Nucl Med. 2017 Dec;58(12):1991-1996. doi: 10.2967/jnumed.117.193532. Epub 2017 Jun 13.
- Background: PubMed 28381537Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696.
- Individual participant dataSharing planned: No
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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.
Sharmila Dorbala, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [68Ga]CBP8 PET/MRI in people with Cardiac Amyloidosis, run by Brigham and Women's Hospital 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 28 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 6 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Mean Standardized Uptake Value (SUVmean) of [68Ga]CBP8 uptake in the heart (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT05619302, which also lists 3 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 6 Jul 2026.