Clinical Translation of a Novel Albumin-Binding PET Radiotracer 68Ga-NEB

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02496013
• Date of registration: 06/07/2015
• Prospective Registration: No
• Primary sponsor: Peking Union Medical College Hospital
• Public title: Clinical Translation of a Novel Albumin-Binding PET Radiotracer 68Ga-NEB
• Scientific title: Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 68Ga-NEB in Healthy Volunteers and Patients With Hepatic Space-occupying Lesions and Suspicious Lymph Nodes Metastasis
• Date of first enrolment: January 2014
• Target sample size: 70
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02496013
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Fang Li, Dr.
• Affiliation: Peking Union Medical College Hospital

• Name: Jingjing Zhang, Dr.

• Name: Zhaohui Zhu, Dr.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lymphedema

Arteriovenous Malformation

Neoplasms Lymph Nodes

Hemangioma

Intervention(s)

Drug: 68Ga-NEB

Primary Outcome(s)

Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging [Time Frame: 1 years]

Secondary Outcome(s)

Routine blood test [Time Frame: 24 hours]

Assessment of liver lesions as determined by standardized uptake value of 68Ga-NEB PET [Time Frame: 2 years]

Routine urine test [Time Frame: 24 hours]

Serum albumin [Time Frame: 24 hours]

Adverse events collection [Time Frame: 2 week]

Secondary ID(s)

ZIAEB000073

PUMCHNM007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute for Biomedical Imaging and Bioengineering (NIBIB)