NCT02496013

Brief Summary

This is an open-label whole-body PET/CT study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-NEB in healthy volunteers and patients with suspected infection. Changes of routine blood and urine tests and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

3.9 years

First QC Date

July 6, 2015

Last Update Submit

April 6, 2017

Conditions

Arteriovenous MalformationHemangiomaNeoplasms Lymph NodesLymphedema

Outcome Measures

Primary Outcomes (1)

  • Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging

    1 years

Secondary Outcomes (5)

  • Adverse events collection

    2 week

  • Routine blood test

    24 hours

  • Serum albumin

    24 hours

  • Routine urine test

    24 hours

  • Assessment of liver lesions as determined by standardized uptake value of 68Ga-NEB PET

    2 years

Study Arms (1)

68Ga-NEB injection and PET/CT scan

EXPERIMENTAL

Patients for blood pool imaging: The patients were intravenously injected with 68Ga-NEB and underwent PET/CT scan 30\~45min after the injection. Patients for lymph node imaging: The patients were locally injected 10\~20MBq 68Ga-NEB and followed by dynamic regional PET acquisitions.

Drug: 68Ga-NEB

Interventions

68Ga-NEBDRUG

68Ga-NEB were injected into the patients before the PET/CT scans

Also known as: 68Ga-NOTA conjugated truncated form of Evans blue
68Ga-NEB injection and PET/CT scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be able to provide a written informed consent
  • Males and females, ≥18 years old；
  • Diagnostic CT or MRI suggesting a diagnosis of liver focal lesion(s). In suspicion of arteriovenous malformations. Newly diagnosed breast cancer and lymph node metastasis is not clear. The tumor will be surgically removed and histological diagnosis will be available. Evaluation of cardiac function.

You may not qualify if:

  • Females planning to bear a child recently or with childbearing potential；
  • Known severe allergy or hypersensitivity to IV radiographic contrast；
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PET centre

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Arteriovenous MalformationsHemangiomaLymphedema

Interventions

68Ga-1,4,7-triazacyclononane-N,N',N''-triacetic acid

Condition Hierarchy (Ancestors)

Vascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasmsLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Fang Li, Dr.

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Zhaohui Zhu, Dr.

CONTACT

+86 10 6915419613611093752@163.com

Jingjing Zhang, Dr.

CONTACT

+86 15101033017zhangjingjingtag@163.com

Study Design

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

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 14, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 7, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)