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

Enterobacteriaceae Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02450942
• Other study ID #: PUMCHNM08
• Status: Recruiting
• Phase: Early Phase 1
• First received: May 13, 2015
• Last updated: April 5, 2017
• Start date: January 2015
• Est. completion date: March 2018

Study information

• Verified date: May 2015
• Source: Peking Union Medical College Hospital
• Contact: Li Fang, MD
• Phone: 86-10-69155502
• Email: lifang[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Enterobacteriaceae Infections
• Infection

Intervention

Drug:
• 18F-FDS
18F-FDS were intravenously injected into the patients 1 h before the PET/CT scans

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Serum albumin	Serum albumin of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.	24 hours
Secondary	Serum creatinine	Serum creatinine of healthy volunteers will be measured at two time points: right before injection and 24 hours after treatment.	24 hours
Secondary	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