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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01527058
First received: January 30, 2012
Last updated: September 8, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: 68Ga-BNOTA-PRGD2
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 68Ga-BNOTA-PRGD2 in Healthy Volunteers and Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Visual and semiquantitative assessment of lesions and biodistribution [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Blood pressure of healthy volunteers will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.

  • Pulse [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Pulse will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.

  • Respiration frequency [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Respiration frequency will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.

  • Temperature [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Temperature will be measured at three time points for each healthy volunteer: right before injection, after scanning, and 24 hours after treatment.

  • Routine blood test [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Routine blood test of healthy volunteers will be measured at two time points: right before and 24 hours after treatment.

  • Routine urine test [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Routine urine test of healthy volunteers will be measured at two time points: right before and 24 hours after treatment.

  • Serum alanine aminotransferase [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Serum alanine aminotransferase of healthy volunteers will be measured at two time points: right before and 24 hours after treatment.

  • Serum albumin [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Serum albumin of healthy volunteers will be measured at two time points: right before and 24 hours after treatment.

  • Serum creatinine [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Serum creatinine of healthy volunteers will be measured at two time points: right before and 24 hours after treatment.

  • Adverse events collection [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Adverse events within 5 days after the injection and scanning of healthy volunteers and patients will be followed and assessed.


Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 68Ga-BNOTA-PRGD2 PET/CT scanning
Determine if 68Ga-BNOTA-PRGD2 PET/CT is safe and effective method for imaging of lung cancer
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

Other Name: 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2

Detailed Description:

Integrin αⅤβ3 is an important member of this receptor family and expressed preferentially on various types of tumor cells and the activated endothelial cells of tumor angiogenesis, but not or very low on the quiescent vessel cells and other normal cells. Therefore, the integrin αⅤβ3 receptor is becoming a valuable target for diagnosis and response evaluation of malignant tumors.

The tri-peptide sequence of arginine-glycine-aspartic acid (RGD) can specifically bind to the integrin αⅤβ3 receptor. Accordingly, a variety of radiolabeled RGD-based peptides have been developed for non-invasive imaging of integrin αⅤβ3 expression via positron emission tomography (PET) or single photon emission computed tomography (SPECT). Among all the RGD radiotracers studied, two PET imaging agents, 18F-Galacto-RGD and 18F-AH111585, have been investigated in clinical trials, and the results demonstrated that both radiotracers allowed the specific imaging of various types of tumors, and the tumor uptake correlated well with the expression of integrin αⅤβ3. Recently, series of RGD dimeric peptides with PEG linkers have been studied. The new types of RGD peptides showed much higher in vitro integrin αⅤβ3-binding affinity than the single RGD tri-peptide sequence, and importantly, they exhibited significantly increased tumor uptake and improved in vivo kinetics in animal models. As a representative, 68Ga-BNOTA-PRGD2 could be easily prepared and exhibited excellent in vivo behaviors in animal models. No adverse reactions are observed in animal models to date.

For the further interests in clinical translation of 68Ga-BNOTA-PRGD2, a open-label dynamic whole-body PET/CT study was designed to investigate 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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers:

    • Males and females, ≥30 and ≤ 70 years old
  • Cancer patients:

    • Males and females, ≥30 years old
    • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527058

Contacts
Contact: Fang Li, MD 86-10-65295502 lifang@pumch.cn
Contact: Zhaohui Zhu, MD, PhD 86-10-13611093752 zzh_1969@yahoo.com.cn

Locations
China
Department of Nuclear Medicine, Peking Union Medical College Hopital Recruiting
Beijing, China, 100730
Contact: Fang Li, MD    86-10-65295502    lifang@pumch.cn   
Contact: Zhaohui Zhu, MD, PhD    86-10-13611093752    zzh_1969@yahoo.com.cn   
Principal Investigator: Fang Li, MD         
Sub-Investigator: Zhaohui Zhu, MD, PhD         
Sub-Investigator: Hongli Jing, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Chair: Fang Li, MD Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01527058     History of Changes
Other Study ID Numbers: PUMCHNM002
Study First Received: January 30, 2012
Last Updated: September 8, 2013
Health Authority: China: National Natural Science Foundation
China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
lung cancer
integrin receptor
68Ga-BNOTA-PRGD2
PET/CT
efficacy and safety

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014