Healthy SubjectsEarly Phase 1NCT07081217
Radiocaine Safety Study
A Early Phase 1 study testing Intravenous Radiocaine in people with Healthy Subjects, run by Lutroo Imaging LLC at 1 site in United States.
Trial summary
This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Intravenous Radiocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2025to Dec 2026
- Phase
- Early Phase 1
- 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
- 18 years and older
- Able to provide written consent
- Willing and able to undergo ECG, imaging, blood sampling, and complete self-assessment rating scales at the specified time points
- Willing and able to participate in all imaging procedures and complete the self-assessment rating scales at the specified time points
Who cannot join
- Body mass index (BMI) of 32 or greater, weight >300 lbs
- Diagnosis of severe depression/anxiety (PROMIS score > 95%) or suicidal ideation
- History of opioid abuse or opioid use disorder
- History of seizures or epilepsy
- History of major Axis I or Axis II psychiatric disorder that might, in the opinion of the investigator, make it difficult for the subject to complete all the procedures (e.g. obsessive-compulsive disorder, bipolar disorder, schizophrenia, or schizoaffective disorder)
- History of cardiac arrhythmia
Show all 18Show fewer
- History of major orthopedic surgery within the last 12 months
- Recent history (previous 6 months) of sodium channel blocker use, including, but not limited to: carbamazepine, lamotrigine, lidocaine, phenytoin, propranolol, or valproate
- Any significant systemic illness or medical condition that could lead to difficulty complying with the study protocol
- Creatinine clearance (calculated using the Cockcroft-Gault formula or measured) < 60 mL/min or serum creatinine >1.5 x ULN
- QTcF >470 msec for females and QTcF >450 msec for males on screening ECG
- MRI-incompatible implants, large tattoos, previous shrapnel injury
- Pregnancy or lactating
- History of contact sport participation, such as football, hockey, or rugby
- Known claustrophobia related to MR or PET-MRI scanners
- Recent blood donation/draw of >1 unit (previous 4 weeks)
- History of hypersensitivity to local anesthetics of the amide type
- Family or personal history of familial malignant hyperthermia
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
Stanford University School of Medicine
Stanford, California, 94305
Clinical Associate Professor of Radiology, (650) 724-4421, srj8@stanford.edu
About this study
Official title: [18F]Radiocaine: Radiation and Radiochemical Safety
This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels. The study enrolls adult volunteers and aims to inform future clinical development in molecular imaging applications. Radiocaine™ is being developed as a potential diagnostic imaging agent and imaging biomarker for the localization and quantification of sodium channel activity.
Read the detailed description
This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels.
The study will enroll six adult volunteers, each of whom will receive a single intravenous dose of Radiocaine™. Serial PET/MR imaging will be performed over several hours post-injection to assess the distribution of the radiotracer in various tissues and organs. Blood and urine samples will be collected at predefined timepoints to support pharmacokinetic and dosimetry modeling. Safety assessments, including vital signs, laboratory tests, and monitoring for adverse events, will be conducted throughout the study.
The primary objectives are to:
- Evaluate the safety and tolerability of a single dose of Radiocaine™ in adults;
- Characterize the biodistribution of Radiocaine™ in key organs and tissues;
- Estimate radiation exposure (dosimetry) to inform future clinical use.
These data will guide dosing strategies, image acquisition timing, and safety parameters for future clinical studies. The results will also support the further development of Radiocaine™ as a potential diagnostic imaging agent and molecular imaging biomarker for the localization and quantification of sodium channel activity in human subjects.
This study is intended for early-stage characterization of Radiocaine™ in preparation for future clinical studies in disease-specific populations.
- Conditions
- Healthy Subjects
- Being tested
- Intravenous Radiocaine
- Keywords
- Radiocaine, PET imaging, medical imaging, diagnostic imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous RadiocaineDiagnostic test
Intravenous injection of Radiocaine
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Not described Receives: Diagnostic Test: Intravenous Radiocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation absorbed dose/Effective dose
Measured: 1 day
Adverse events
Presence/absence of adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start17 Jun 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lutroo Imaging LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081217
- Sponsor's protocol ID
- LTR-001
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]Radiocaine: Radiation and Radiochemical Safety
- ClinicalTrials.gov ID
- NCT07081217
- Acronym / sponsor ID
- LTR-001
- Conditions
- Healthy Subjects
- Keywords
- Radiocaine, PET imaging, medical imaging, diagnostic imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Lutroo Imaging LLCIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jul 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 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels. The study enrolls adult volunteers and aims to inform future clinical development in molecular imaging applications. Radiocaine™ is being developed as a potential diagnostic imaging agent and imaging biomarker for the localization and quantification of sodium channel activity.
Detailed description
This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels.
The study will enroll six adult volunteers, each of whom will receive a single intravenous dose of Radiocaine™. Serial PET/MR imaging will be performed over several hours post-injection to assess the distribution of the radiotracer in various tissues and organs. Blood and urine samples will be collected at predefined timepoints to support pharmacokinetic and dosimetry modeling. Safety assessments, including vital signs, laboratory tests, and monitoring for adverse events, will be conducted throughout the study.
The primary objectives are to:
- Evaluate the safety and tolerability of a single dose of Radiocaine™ in adults;
- Characterize the biodistribution of Radiocaine™ in key organs and tissues;
- Estimate radiation exposure (dosimetry) to inform future clinical use.
These data will guide dosing strategies, image acquisition timing, and safety parameters for future clinical studies. The results will also support the further development of Radiocaine™ as a potential diagnostic imaging agent and molecular imaging biomarker for the localization and quantification of sodium channel activity in human subjects.
This study is intended for early-stage characterization of Radiocaine™ in preparation for future clinical studies in disease-specific populations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Diagnostic Test: Intravenous Radiocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Able to provide written consent
- Willing and able to undergo ECG, imaging, blood sampling, and complete self-assessment rating scales at the specified time points
- Willing and able to participate in all imaging procedures and complete the self-assessment rating scales at the specified time points
Key exclusion criteria (18 listed)
- Body mass index (BMI) of 32 or greater, weight >300 lbs
- Diagnosis of severe depression/anxiety (PROMIS score > 95%) or suicidal ideation
- History of opioid abuse or opioid use disorder
- History of seizures or epilepsy
- History of major Axis I or Axis II psychiatric disorder that might, in the opinion of the investigator, make it difficult for the subject to complete all the procedures (e.g. obsessive-compulsive disorder, bipolar disorder, schizophrenia, or schizoaffective disorder)
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 |
|---|---|---|
| Intravenous RadiocaineIntravenous injection of Radiocaine | Diagnostic test | Healthy subjects |
Primary outcome
Radiation absorbed dose/Effective dose
Time frame: 1 day
Adverse events
Time frame: 30 days
Presence/absence of adverse events
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 27 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intravenous Radiocaine in people with Healthy Subjects, run by Lutroo Imaging 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 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Chief Medical Officer (877-310-1326, info@lutrooimaging.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation absorbed dose/Effective dose (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?
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 27 Aug 2026.