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

NCT01542073 | Unknown Early Phase 1 DMC

• 1 other identifier: PUMCHNM003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Visual and semiquantitative assessment (Standardized Uptake Values = SUVs) of myocardial infarction region and normal left ventricular wall

  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.

  1 year

Secondary Outcomes (1)

• Number of participants with adverse events

  1 year

Study Arms (1)

68Ga-BNOTA-PRGD2 cardiac PET/CT scanning

EXPERIMENTAL

We will perform 68Ga-BNOTA-PRGD2 cardiac PET/CT scanning on myocardial infarction patients to determine its value.

Drug: 68Ga-BNOTA-PRGD2

Interventions

68Ga-BNOTA-PRGD2 DRUG

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)

Also known as: 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2

68Ga-BNOTA-PRGD2 cardiac PET/CT scanning

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Nuclear Medicine, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Interventions

68gallium-BNOTA-PRGD2

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Zhaohui Zhu, MD

  Department of Nuclear Medicine, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

86-10-13611093752; zzh_1969@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 1, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 7, 2017

Record last verified: 2014-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)