TheranosticTrials.org

Clinical Trial · NCT01527058

68Ga-BNOTA-PRGD2 PET/CT in Healthy Volunteers and Lung Cancer Patients

Overview

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 68Ga-BNOTA-PRGD2 in healthy volunteers and lung cancer patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be intravenously injected into healthy volunteers and lung cancer patients. 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.

Sponsor

Peking Union Medical College Hospital

Phase

Early Phase 1

Contacts

Fang Li, MD (STUDY_CHAIR)

Fang Li, MD (CONTACT)

lifang@pumch.cn

86-10-65295502

Zhaohui Zhu, MD, PhD (CONTACT)

zzh_1969@yahoo.com.cn

86-10-13611093752

ClinicalTrials.gov

NCT01527058

Drug / Compound

BNOTA-PRGD2

Isotope(s):
Target(s):
  • αvβ3
Ligand Class: Peptides
Chelator: NOTA
Linker: PEG3

Eligibility

Inclusion

  • CT and/or 18F-FDG PET/CT diagnosis in suspicion of primary or recurrent lung cancer.
  • The lung cancer will be histologically confirmed or results of histology will be available.
  • Cancer patients:
  • Healthy volunteers:

Exclusion

  • Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
  • Females planning to bear a child recently or with childbearing potential
  • Renal function: serum creatinine \>3.0 mg/dL (270 μM/L)
  • Patients not able to enter the bore of the PET/CT scanner.
  • Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
  • 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.
  • Known severe allergy or hypersensitivity to IV radiographic contrast.