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New imaging agent radiocaine enters human safety testing

NCT ID NCT07081217

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This early-phase study tests the safety and radiation of Radiocaine, a new radioactive tracer for PET scans. Six healthy adult volunteers will receive an injection and be monitored for side effects and radiation exposure. The goal is to see if Radiocaine can safely light up nerve activity in future imaging studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiocaine (a radioactive tracer for PET scans)
What this could lead to
If successful, this could lead to a new way to see nerve activity in the body using a PET scan.
What could go wrong
This is a very early, tiny trial (6 people) just checking safety and radiation. It may not lead to a useful diagnostic tool.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 6 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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As listed by the trial registrant

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How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Stanford University School of Medicine

    RECRUITING

    Stanford, California, 94305, United States

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