Parkinson Disease (PD)Phase 2IRP101-231NCT07176286
18F-mFBG Cardiac Uptake With Lewy Body Dementia
A Phase 2 study testing 18F-MFBG in people with Parkinson Disease (PD) and Lewy Body Dementia (LBD), 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 the effect of neurodegenerative diseases on myocardial sympathetic innervation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease (PD), Lewy Body Dementia (LBD)
- What is being tested?
- 18F-MFBG
- 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
- 30 Apr 2026to 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
- 1. ≥18 years of age at study entry. 2. Able and willing to comply with study procedures and signed and dated informed consent is obtained.
- 3. A male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a serum pregnancy test performed at screening is negative.
- 4. All subjects: Judged clinically stable for at least 30 days before enrolment into the study and remains stable to the time of the study imaging procedure.
- For Lewy body disease subjects (Study Cohort I):
- 5. The subject has a diagnosis of either PD or DLB based on accepted clinical criteria at least 6 months before enrollment into the study.
- For non-Lewy body disease subjects (Study Cohort II):
- 6. The subject has a diagnosis of neurological or neurodegenerative disease for which neither PD nor DLB is judged likely by a neurologist based on accepted clinical and imaging criteria.
Who cannot join
- 1. Previously entered into this study or has participated in any other investigational product or medical device study within 30 days of enrollment.
- 2. History or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.
- 3. Presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 1 year or where participation in the study might compromise the management of the subject or other reason that in the judgment of the investigator(s) makes the subject unsuitable for participation in the study.
- 4. Documented ischemic heart disease (prior myocardial infarction, unstable angina, etc) or a diagnosis of heart failure of ischemic or non-ischemic etiology.
- 5. Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma.
- 6. The subject is claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to 20 minutes.
- 7. Renal insufficiency (serum creatinine >3.0 mg/dL). 8. Uses medications that are known to interfere with uptake of NET-dependent agents and these medications cannot be safely withheld 24 hours before study procedures.
- 9. Participated in a research study using ionizing radiation in the previous 12 months such that participation in the study might result in a total effective dose from research procedures exceeding 50 milliSieverts during that time interval.
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
Houston Methodist Neurological Institute
Houston, Texas, 77030
Juan B Toledo, MD, 713-441-1150, jtoledo@houstonmethodist.org
About this study
Official title: An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F-mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With and Without Lewy Body Diseases
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.
Read the detailed description
Over the past 40 years, significant efforts have been made to develop imaging techniques to monitor the heart's autonomic nervous system, particularly the sympathetic system and its key neurohormone, norepinephrine (NE). In heart disease, NE function is often disrupted, leading to reduced NE uptake and transporter expression, which can contribute to heart failure, arrhythmias, and sudden cardiac death. Similar NE system dysfunction is also seen in neurological conditions like pure autonomic failure (PAF), Parkinson's disease (PD), and Dementia with Lewy Bodies (DLB), which are associated with Lewy body deposits in the nervous system. Most research on myocardial sympathetic neuronal imaging has focused on NE-analogues labeled with gamma- or positron-emitting radioisotopes. The most commonly studied agent is 123I-mIBG, which provides semi-quantitative data. However, its results depend heavily on imaging equipment and techniques, making global standardization difficult. Additionally, accurately measuring myocardial uptake and clearance is challenging with SPECT, even when using correction methods. While most cardiac mIBG research has focused on patients with heart disease, a significant number of studies have examined the effect of Lewy body disease on myocardial sympathetic innervation. These studies have consistently demonstrated a significant reduction in myocardial mIBG uptake. mIBG scintigraphy has high sensitivity (88%) and specificity (85%) for distinguishing Parkinson's disease (PD) from other Parkinsonism disorders. In a study of 123I-mIBG scans, the heart/mediastinum ratio (HMR) showed 68.9% sensitivity and 89.1% specificity for differentiating dementia with Lewy bodies (DLB) from Alzheimer's disease (AD). Neurologists and movement disorder specialists find mIBG imaging helpful for assessing suspected Lewy body disease. Positron-emission tomography (PET) is the preferred method for high-resolution imaging of cellular functions. This study uses 18F-meta-fluorobenzylguanidine (18F-mFBG), a new radiopharmaceutical similar in structure to 123I-mIBG but with faster pharmacokinetics and elimination. Compared to 123I-mIBG, 18F-mFBG clears more quickly from the blood and target organs, resulting in better heart imaging quality and reliability. While most research on 18F-mFBG has focused on imaging neural crest tumors like neuroblastoma and pheochromocytoma, its performance is expected to be strong based on prior experience with 123I-mIBG. With the greater sensitivity and resolution of PET imaging compared to planar and SPECT techniques, it is expected that 18F-mFBG imaging will be less procedure-dependent than 123I-mIBG and provide the reliable and reproducible quantitative accuracy necessary to support use of this agent for clinical patient studies.
- Conditions
- Parkinson Disease (PD), Lewy Body Dementia (LBD)
- Being tested
- 18F-MFBG
- Keywords
- IRP101-231, 18F-mFBG
- Medical subject headings
- Parkinson Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-MFBGDrug
Intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG followed by whole body PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD) | Active comparator | All subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes. Receives: Drug: 18F-MFBG |
| Cohort 2: neurologic disease due to non-Lewy body pathology. | Active comparator | All subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes. Receives: Drug: 18F-MFBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Quantify the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of subjects with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)).
All image data will be analyzed to develop and validate quantitative measures of global and regional myocardial uptake of 18F-mFBG at two times between injection and 60 minutes post-administration. The data from subjects without Lewy body disease will be used in comparisons with equivalent results for Lewy body disease subjects. Results for subjects imaged in this study will also be compared with historical data from imaging of healthy control subjects without heart disease.
Measured: 6 months
Secondary outcomes (3)
Cohorts 1 and 2: Quantify 18F-mFBG whole-body activity distribution in Lewy body disease subjects (voxel, regional, and global basis) at 30-minutes post-administration
Normalized uptake measurements (counts/voxel/MBq administered) determined from Lewy body disease subjects will be used for quantitative comparisons to non-Lewy body disease and historical healthy control subject scans.
Measured: 6 months
Cohort 1 and 2: 18F-mFBG PET quantitative assessment at 60 minutes
18F-mFBG myocardial activity in Lewy body disease subjects (voxel, regional, and global basis) at 60-minutes post-administration compared to non-Lewy body disease subjects.
Measured: 6 months
Cohorts 1 and 2: Global myocardial 18F-mFBG activity in Lewy body disease subjects compared to non-Lewy body disease subjects.
Global myocardial 18F-mFBG activity in Lewy body disease subjects at 30-minutes post-administration, as a proportion of total-body activity, compared to non-Lewy body disease subjects.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start30 Apr 2026
- 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.
- Other trials for Parkinson Disease (PD)Studies 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
- Model description
- This is an exploratory study of two study cohorts. Cohort 1 will consist of a minimum of five and maximum of ten participants with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)). Cohort 2 will consist of participants with neurologic disease due to non-Lewy body pathology.
- 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)
- Responsible party
- Sponsor
- Investigators
- Juan B Toledo, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176286
- Sponsor's protocol ID
- IRP101-231
- Acronym
- IRP101-231
- Status last verified
- Jun 2026
- First submitted
- 10 Sep 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
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 and Without Lewy Body Diseases
- ClinicalTrials.gov ID
- NCT07176286
- Acronym / sponsor ID
- IRP101-231 / IRP101-231
- Conditions
- Parkinson Disease (PD), Lewy Body Dementia (LBD)
- Keywords
- IRP101-231, 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)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Sep 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 the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.
Detailed description
Over the past 40 years, significant efforts have been made to develop imaging techniques to monitor the heart's autonomic nervous system, particularly the sympathetic system and its key neurohormone, norepinephrine (NE). In heart disease, NE function is often disrupted, leading to reduced NE uptake and transporter expression, which can contribute to heart failure, arrhythmias, and sudden cardiac death. Similar NE system dysfunction is also seen in neurological conditions like pure autonomic failure (PAF), Parkinson's disease (PD), and Dementia with Lewy Bodies (DLB), which are associated with Lewy body deposits in the nervous system. Most research on myocardial sympathetic neuronal imaging has focused on NE-analogues labeled with gamma- or positron-emitting radioisotopes. The most commonly studied agent is 123I-mIBG, which provides semi-quantitative data. However, its results depend heavily on imaging equipment and techniques, making global standardization difficult. Additionally, accurately measuring myocardial uptake and clearance is challenging with SPECT, even when using correction methods. While most cardiac mIBG research has focused on patients with heart disease, a significant number of studies have examined the effect of Lewy body disease on myocardial sympathetic innervation. These studies have consistently demonstrated a significant reduction in myocardial mIBG uptake. mIBG scintigraphy has high sensitivity (88%) and specificity (85%) for distinguishing Parkinson's disease (PD) from other Parkinsonism disorders. In a study of 123I-mIBG scans, the heart/mediastinum ratio (HMR) showed 68.9% sensitivity and 89.1% specificity for differentiating dementia with Lewy bodies (DLB) from Alzheimer's disease (AD). Neurologists and movement disorder specialists find mIBG imaging helpful for assessing suspected Lewy body disease. Positron-emission tomography (PET) is the preferred method for high-resolution imaging of cellular functions. This study uses 18F-meta-fluorobenzylguanidine (18F-mFBG), a new radiopharmaceutical similar in structure to 123I-mIBG but with faster pharmacokinetics and elimination. Compared to 123I-mIBG, 18F-mFBG clears more quickly from the blood and target organs, resulting in better heart imaging quality and reliability. While most research on 18F-mFBG has focused on imaging neural crest tumors like neuroblastoma and pheochromocytoma, its performance is expected to be strong based on prior experience with 123I-mIBG. With the greater sensitivity and resolution of PET imaging compared to planar and SPECT techniques, it is expected that 18F-mFBG imaging will be less procedure-dependent than 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
- Model description
- This is an exploratory study of two study cohorts. Cohort 1 will consist of a minimum of five and maximum of ten participants with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)). Cohort 2 will consist of participants with neurologic disease due to non-Lewy body pathology.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD) | Active comparator | Drug: 18F-MFBGAll subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes. |
| Cohort 2: neurologic disease due to non-Lewy body pathology. | Active comparator | Drug: 18F-MFBGAll subjects will receive an intravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG. At 30 minutes post-administration, whole-body imaging will be performed from the head to the pelvis. A static image of the thorax will be acquired at 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. ≥18 years of age at study entry. 2. Able and willing to comply with study procedures and signed and dated informed consent is obtained.
- 3. A male or a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a serum pregnancy test performed at screening is negative.
- 4. All subjects: Judged clinically stable for at least 30 days before enrolment into the study and remains stable to the time of the study imaging procedure.
- 5. The subject has a diagnosis of either PD or DLB based on accepted clinical criteria at least 6 months before enrollment into the study.
- 6. The subject has a diagnosis of neurological or neurodegenerative disease for which neither PD nor DLB is judged likely by a neurologist based on accepted clinical and imaging criteria.
Key exclusion criteria (8 listed)
- 1. Previously entered into this study or has participated in any other investigational product or medical device study within 30 days of enrollment.
- 2. History or suspicion of significant allergic reaction or anaphylaxis to any components of the 18F-mFBG imaging agent.
- 3. Presents with any other clinically active, serious, life-threatening disease with a life expectancy of less than 1 year or where participation in the study might compromise the management of the subject or other reason that in the judgment of the investigator(s) makes the subject unsuitable for participation in the study.
- 4. Documented ischemic heart disease (prior myocardial infarction, unstable angina, etc) or a diagnosis of heart failure of ischemic or non-ischemic etiology.
- 5. Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma.
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-MFBGIntravenous injection of 222-370 MBq (6-10 mCi) 18F-mFBG followed by whole body PET imaging. | Drug | Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD), Cohort 2: neurologic disease due to non-Lewy body pathology. |
Primary outcome
Cohort 1: Quantify the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of subjects with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)).
Time frame: 6 months
All image data will be analyzed to develop and validate quantitative measures of global and regional myocardial uptake of 18F-mFBG at two times between injection and 60 minutes post-administration. The data from subjects without Lewy body disease will be used in comparisons with equivalent results for Lewy body disease subjects. Results for subjects imaged in this study will also be compared with historical data from imaging of healthy control subjects without heart disease.
3 secondary outcomes
Cohorts 1 and 2: Quantify 18F-mFBG whole-body activity distribution in Lewy body disease subjects (voxel, regional, and global basis) at 30-minutes post-administration
Time frame: 6 months
Cohort 1 and 2: 18F-mFBG PET quantitative assessment at 60 minutes
Time frame: 6 months
Cohorts 1 and 2: Global myocardial 18F-mFBG activity in Lewy body disease subjects compared to non-Lewy body disease subjects.
Time frame: 6 months
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.
- 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.
Juan B Toledo, MD principal investigator
The Methodist Hospital Research Institute
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-MFBG in people with Parkinson Disease (PD) and Lewy Body Dementia (LBD), 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 7 inclusion and 8 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 Research Coordinator (346-238-2677, Jrrodriguezgaytan@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Quantify the extent and degree of global and regional reduced 18F-mFBG myocardial uptake on PET/CT (or PET/MR) of subjects with known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)). (time frame: 6 months). 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 Jul 2026.