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

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Jul 31, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new substance called [18F]-fluoromannitol, which is used in a special type of imaging test called a PET scan. This substance helps doctors see inside the body to detect infections or medical problems. The main goal of the study is to find out if this substance is safe to use in healthy adults and to learn how it moves through the body. While this study involves healthy volunteers now, in the future, this substance might help people with conditions like Sickle Cell Disease, cancer, or joint implants by showing if they have infections.

People eligible to take part are healthy adults between 18 and 75 years old who don’t have active infections or certain medical conditions like lung or liver disease. Women who could have children must not be breastfeeding during the study because of possible risks to the baby. Participants will undergo a PET scan after receiving the substance, and the researchers will closely monitor their safety. It’s important that participants can tolerate the scan and agree to the study’s rules. This study is not yet recruiting volunteers but aims to help improve medical imaging for better diagnosis in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy volunteers, 18-75 years of age.
• • Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
• • Informed consent signed by participant according to the guidelines of the institutional review board.
• Exclusion Criteria:
• • Participant currently has a fever or other symptoms concerning for an active infection or is currently undergoing treatment for an active infection.
• • Participant has been diagnosed and/or treated for a known or suspected bacterial infection within the past 60 days.
• • Participant has known disease of the lung, liver, kidneys, gastrointestinal tract, bones/joints, or known immune suppression or autoimmune disease that is likely to have active inflammation (examples to exclude: Crohn's disease, COPD; example to i include: well controlled asthma)
• • Participant has prosthetic or indwelling device(s) currently or has had one in the past 60 days.
• • Participant is pregnant or breastfeeding.
• • Estimated glomerular filtration rate \< 45 ml/minute/1.73m2
• • Use of drugs known to have interaction or be affected by mannitol within 60 days of enrollment.
• • Participant has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol, including being unable to tolerate the PET scan procedures.
• • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• • Participant is currently participating in another study subject to an IND.