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

NCT01527058 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-04-07

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

68Ga-BNOTA-PRGD2

Cancer patients, single intravenous bolus injection of nearly 111 MBq 68Ga-NOTA-PRGD2 on day one of the treatment period, dynamic whole-body PET/CT for determination of effective dose, kinetics of 68Ga-BNOTA-PRGD2 in blood, organs, and tumors Healthy volunteers, single intravenous bolus injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 on day one of the treatment period, dynamic whole-body PET/CT for determination of effective dose, kinetics of 68Ga-BNOTA-PRGD2 in blood and organs

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Fang Li, MD · Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01527058 on ClinicalTrials.gov