18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection

Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection

This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 18F-FDS in healthy volunteers and patients with suspected infection. A single dose of nearly 370 MBq 18F-FDS will be intravenously injected into healthy volunteers and patients with suspected infection. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.

Study Overview

• Status: Unknown
• Conditions: Enterobacteriaceae Infections
• Intervention / Treatment: Drug: 18F-FDS

Detailed Description

In clinical microbiology, pathogenic enterobacteriaceae are differentiated from other organisms by selectively metabolizing sorbitol. They exclusively express the enzyme sorbitol-6-phosphate dehydrogenase, which is the enzyme responsible for initiating sorbitol metabolism. 2-[18F]-fluorodeoxysorbitol (18F-FDS) is a positron-emitting analog of sorbitol. The substitution of the hydroxyl group by fluorine at the C-2 position, however, completely abrogates the recognition by mammalian sorbitol dehydrogenase.18F-FDS could be a suitable probe to selectively label and tomographically image enterobacteriaceae in vivo.

For further interests in clinical translation of 18F-FDS, an open-label dynamic whole-body PET/CT study was designed to investigate radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 18F-FDS in healthy volunteers and patients with suspected infection. A single dose of nearly 370 MBq 18F-FDS will be intravenously injected into healthy volunteers and patients with suspected infection. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Li Fang, MD; Phone Number: 86-10-69155502; Email: lifang@pumch.cn
• Study Contact Backup: Name: Zhu Zhaohui, MD, PhD; Phone Number: 86-10-13611093752; Email: 13611093752@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Zhaohui Zhu, MD; Phone Number: 86-10-69154196; Email: 13611093752@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers:

  o Males and females, ≥18 years old

• Infectious patients:

  • Males and females, ≥18 years old
  • Characteristic clinical signs, symptoms and laboratory tests suggesting the diagnosis of infectious disease.
  • The diagnosis of infection is based on The Centres for Disease Control and Prevention (CDC) criteria for diagnosing infection. They rely on a combination of clinical, radiological, operative, microbiological, and histological findings, in addition to results of other laboratory tests, such as the white blood cell count, erythrocyte sedimentation rate, and C reactive protein value.

Exclusion Criteria:

• Females planning to bear a child recently or with childbearing potential
• Renal function: serum creatinine >3.0 mg/dL (270 μM/L)
• Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
• Known severe allergy or hypersensitivity to IV radiographic contrast.
• Patients not able to enter the bore of the PET/CT scanner.
• Inability to lie still for the entire imaging time because of cough, pain, etc.
• Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
• Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 18F-FDS injection and PET/CT scan; The patients were intravenously injected with 18F-FDS and underwent PET/CT scan 1 h after the injection.	Drug: 18F-FDS; 18F-FDS were intravenously injected into the patients 1 h before the PET/CT scans; Other Names: 2-[18F]-fluorodeoxysorbitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual and semiquantitative assessment of lesions and biodistribution	Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of tumor and organs will be measured.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure of healthy volunteers will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.	24 hours
Pulse	Pulse will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.	24 hours
Respiration frequency	Respiration frequency will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.	24 hours
Temperature	Temperature will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.	24 hours
Routine blood test	Routine blood test of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.	24 hours
Routine urine test	Routine urine test of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.	24 hours
Serum alanine aminotransferase	Serum alanine aminotransferase of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.	24 hours
Serum albumin	Serum albumin of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.	24 hours
Serum creatinine	Serum creatinine of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.	24 hours
Adverse events collection	Adverse events within 5 days after the injection and scanning of healthy volunteers and patients will be followed and assessed.	5 days

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Publications and helpful links

General Publications

• Kong Z, Wang Y, Ma W, Cheng X. Role of 18F-fluorodeoxyglucose (FDG) and 18F-2-fluorodeoxy sorbitol (FDS) in autoimmune hypophysitis: a case report. BMC Endocr Disord. 2020 Jun 9;20(1):84. doi: 10.1186/s12902-020-00567-8.
• Yao S, Xing H, Zhu W, Wu Z, Zhang Y, Ma Y, Liu Y, Huo L, Zhu Z, Li Z, Li F. Infection Imaging With (18)F-FDS and First-in-Human Evaluation. Nucl Med Biol. 2016 Mar;43(3):206-14. doi: 10.1016/j.nucmedbio.2015.11.008. Epub 2015 Dec 4.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ANTICIPATED): January 1, 2018
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 18, 2015
• First Posted (ESTIMATE): May 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Enterobacteriaceae Infections
• Other Study ID Numbers: PUMCHNM08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO