Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

68Ga-BNOTA-PRGD2 PET/CT in Evaluation of Myocardial Infarction (GRGDMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01542073
First received: February 21, 2012
Last updated: November 1, 2014
Last verified: November 2014
  Purpose

This is an open-label PET/CT (positron emission tomography/computed tomography) study to investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in evaluation of myocardial infarction. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be intravenously injected into myocardial infarction patients. Visual and semiquantitative method will be used to assess the 68Ga-BNOTA-PRGD2 PET/CT cardiac images and compared to the 99mTc-MIBI SPECT myocardial perfusion images and the 18F-FDG metabolism images.


Condition Intervention Phase
Coronary Artery Disease
Drug: 68Ga-BNOTA-PRGD2
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 68Ga-BNOTA-PRGD2 PET/CT in Evaluation of Angiogenesis of Myocardial Infarction and the Comparison With Cardiac Perfusion and Metabolism

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Visual and semiquantitative assessment (Standardized Uptake Values = SUVs) of myocardial infarction region and normal left ventricular wall [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Visual analysis will be performed by concensus reading by at least 3 experienced nuclear medicine physician and will compare to 99mTc-MIBI myocardial perfusion imaging and 18F-FDG myocardial metablism imaging obtained within a week. The semiquantitative analysis will be performed by the same person for all the cases, and the MI region standardized uptake values (SUVs), the SUV ratios (SUV of MI/SUV normal LV), and other organs' SUVs will be measured.


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Adverse events within 5 days after 68Ga-BNOTA-PRGD2 injection and PET/CT scanning of the patients will be collected and assessed.


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 68Ga-BNOTA-PRGD2 cardiac PET/CT scanning
We will perform 68Ga-BNOTA-PRGD2 cardiac PET/CT scanning on myocardial infarction patients to determine its value.
Drug: 68Ga-BNOTA-PRGD2
Intravenous injection of one dosage of 111 MBq 68Ga-BNOTA-PRGD2. Tracer doses of 68Ga-BNOTA-PRGD2 will be used to image angiogenesis of myocardial infarction area by positron emission tomography / computed tomography (PET/CT)
Other Name: 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2

Detailed Description:

Integrin αvβ3 is an important member of integrin receptor family and expressed preferentially on regenerative vascular endothelial cells and some tumor cells, but not or very low expressed on the quiescent vessel cells and other normal cells. The αvβ3 integrin is a key mediator of angiogenesis and thus may be an important diagnostic and therapeutic target associated with myocardial repair processes after ischaemic injury.

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 in Myocardial Infarction (MI), 18F-Galacto-RGD and 99mTc-RGD has been investigated clinically in acute MI patients, showing focal tracer retention localized in the infarcted area. Recently, series of RGD dimeric peptides with PEG linkers have been developed. The new types of RGD peptides showed much higher in vitro integrin αvβ3-binding affinity than the single RGD tri-peptide sequence. 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 both animal and human studies to date.

For the further interests in clinical translation of 68Ga-BNOTA-PRGD2, a open-label PET/CT study was designed to investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in myocardial infarction patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be intravenously injected into the myocardial infarction patients. Visual and semiquantitative method will be used to assess the PET/CT images. 99mTc-MIBI myocardial perfusion SPECT images and 18F-FDG metabolism images will be used for co-registrated comparison.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Myocardial infarction patients:

  • Males and females
  • ≥30 years old
  • Patients had myocardial infarction diagnosis (fulfilling two or three symptoms: clinical history of ischaemic type chest pain lasting for more than 20 minutes, changes in serial ECG tracings, rise and fall of serum cardiac biomarkers such as creatine kinase-MB fraction and troponin)

Exclusion Criteria:

  • Females planning to bear a child recently or with childbearing potential
  • Have other kinds of heart diseases
  • 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: NCT01542073

Contacts
Contact: Zhaohui Zhu, MD 86-10-13611093752 zzh_1969@yahoo.com.cn

Locations
China, Beijing
Department of Nuclear Medicine, Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Zhaohui Zhu, MD    86-10-13611093752    zhuzhh@pumch.cn   
Contact: Chenxi Wu, MD    86-10-15911068700    cxwu2012@gmail.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Zhaohui Zhu, MD Department of Nuclear Medicine, Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01542073     History of Changes
Other Study ID Numbers: PUMCHNM003
Study First Received: February 21, 2012
Last Updated: November 1, 2014
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
myocardial infarction
angiogenesis
integrin receptor imaging
68Ga-BNOTA-PRGD2

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Infarction
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014