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

NCT02450942 | Unknown Early Phase 1 DMC

• 1 other identifier: PUMCHNM08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enterobacteriaceae Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Blood pressure

  24 hours

• Pulse

  24 hours

• Respiration frequency

  24 hours

• Temperature

  24 hours

• Routine blood test

  24 hours

Study Arms (1)

18F-FDS injection and PET/CT scan

EXPERIMENTAL

The patients were intravenously injected with 18F-FDS and underwent PET/CT scan 1 h after the injection.

Drug: 18F-FDS

Interventions

18F-FDS DRUG

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

Also known as: 2-[18F]-fluorodeoxysorbitol

18F-FDS injection and PET/CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 32517690 DERIVED

• 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.

  PMID: 26924501 DERIVED

MeSH Terms

Conditions

Enterobacteriaceae Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Zhaohui Zhu

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Li Fang, MD

CONTACT

86-10-69155502; lifang@pumch.cn

Zhu Zhaohui, MD, PhD

CONTACT

86-10-13611093752; 13611093752@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 21, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 7, 2017

Record last verified: 2015-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)