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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Coronary Artery Disease	Drug: 68Ga-BNOTA-PRGD2	Early Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	February 2012
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	December 2017

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Visual and semiquantitative assessment (Standardized Uptake Values = SUVs) of myocardial infarction region and normal left ventricular wall [ Time Frame: 1 year ]
   Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician and will compare to 99mTc-MIBI myocardial perfusion imaging and 18F-FDG myocardial metabolism 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 :

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

Eligibility Criteria

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Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:	NCT01542073 History of Changes
Other Study ID Numbers:	PUMCHNM003
First Posted:	March 1, 2012
Last Update Posted:	April 7, 2017
Last Verified:	November 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Peking Union Medical College Hospital:

myocardial infarction; angiogenesis; integrin receptor imaging; 68Ga-BNOTA-PRGD2

Additional relevant MeSH terms:

Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Ischemia; Pathologic Processes	Necrosis; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases