99mTc-3PRGD2 SPECT/CT in Lung Cancer Patients (TcRGDLC)

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:
NCT01737112
First received: November 27, 2012
Last updated: September 8, 2013
Last verified: September 2013
  Purpose

This is an open-label SPECT/CT (single photon emission computed tomography / computed tomography) study to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in evaluation of lung cancer patients. A single dose of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion of lung cancer. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients.


Condition Intervention Phase
Lung Cancer
Drug: 99mTc-3PRGD2
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: Safety and Diagnostic Performance of 99mTc-3PRGD2 SPECT/CT in Evaluation of 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 tumor to background ratios(T/B) will be measured.


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


Estimated Enrollment: 100
Study Start Date: February 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: 99mTc-3PRGD2 SPECT/CT scanning
Determine if 99mTc-3PRGD2 SPECT/CT is safe and effective in diagnosis and evaluation of lung cancer patients.
Drug: 99mTc-3PRGD2
For patients in suspicion of lung cancer, single intravenous bolus injection of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and thoracic SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body.
Other Name: 99mTc-HYNIC-3PRGD2

Detailed Description:

Integrin αvβ3 is an important member of integrin receptor family and expressed preferentially on the activated endothelial cells of angiogenesis and some types of tumor cells, 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 single photon emission computed tomography (SPECT)or positron emission tomography (PET). Among all the RGD radiotracers studied, several RGD monomers have been investigated in clinical trials, and the preliminary results demonstrated specific imaging of various types of tumors, and the tumor uptake correlated well with the level of integrin αvβ3 expression. Recently, several 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, 99mTc-3PRGD2 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 99mTc-3PRGD2, an open-label SPECT/CT study was designed to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in lung cancer patients. A single dose of nearly 11.1 MBq/kg body weight 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the lung cancer patients. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Adverse events will also be observed in the patients.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, ≥30 years old
  • Thoracic 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
  • 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.
  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: NCT01737112

Contacts
Contact: Fang Li, MD 86-10-69155502 lifang@pumch.cn
Contact: Zhaohui Zhu, MD 86-10-69154196 zhu_zhaohui@yahoo.cn

Locations
China
Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science Recruiting
Beijing, China, 100730
Contact: Fang Li, MD    86-10-69155502    lifang@pumch.cn   
Contact: Zhaohui Zhu, MD    86-10-69154196    zhu_zhaohui@yahoo.cn   
Principal Investigator: Zhaohui Zhu, 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: NCT01737112     History of Changes
Other Study ID Numbers: PUMCHNM05
Study First Received: November 27, 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 αvβ3 receptor
99mTc-3PRGD2
SPECT/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