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PAKMANN: Kinetics and Safety of [18F]-fluoromannitol

About this study

Bacterial infections that start deep inside the body may be hard to diagnose. These infections are especially difficult to diagnose in people with:

  • Immune systems that do not work properly
  • Sickle cell disease or cancer
  • Prosthetic joint implants or other devices

Bacterial cultures and imaging tests such as positron emission tomography (PET) scans help doctors identify infections. But these methods may not work well if a disease is deep in the body or if a person has another condition at the same time, including inflammation, cancer, or a prosthetic device such as an artificial knee. Better ways are needed to find infection deep in the tissues.

PET scans use a substance that lets off a small amount of radiation, known as a radiotracer. When the radio tracer touches certain things in the body, it gives off harmless light that doctors can detect. Tracers are used during PET scans to help detect disease or infection.

This study will use a new radiotracer, [18F]-fluoromannitol. 

We want to find out:

  • How well the body tolerates this tracer
  • How it moves through the body
  • If it helps doctors see infections better

This is the first time this tracer has been used for this purpose in people. It is not yet approved by the United States Food and Drug Administration (FDA). 

The amount of radiation in the tracer is small. As part of this study, healthy adults will:

  • Give blood and urine samples
  • Get the tracer through an IV
  • Have 3 PET scans and heart scans
  • Fill out questionnaires about their medical history

Eligibility overview

  • Healthy adult
  • 18–75 years old
  • No prosthetic or indwelling device 
  • Females must not be pregnant or nursing
  • No surgeries that have removed organs (such as gallbladder or kidney)
  • No current or recent treatment for bacterial infection
  • No current or recently diagnosed autoimmune disorders 

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

Positron Emission Tomography (PET) Contract Agent Kinetics and Safety: [18F]-Fluoromannitol (PAKMANN)

Study goal:

To study the tolerance and safety of [18F]-fluoromannitol in healthy adult volunteers and to see how the tracer moves through their bodies.

Diagnosis:

Healthy volunteer 

Age:

18–75 years old

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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