68Ga-BNOTA-PRGD2 PET/CT in Evaluation of Stroke (GRGDS)

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:
NCT01656785
First received: August 1, 2012
Last updated: September 8, 2013
Last verified: September 2013
  Purpose

This is an open-label brain PET/CT (positron emission tomography/computed tomography) study to investigate the diagnostic performance of 68Ga-BNOTA-PRGD2 in evaluation of stroke patients in convalescence. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be intravenously injected into the patients. Visual and semi-quantitative method will be used to assess the PET/CT images. Changes of 18F-FDG PET/CT, enhanced brain MRI or CT, and any adverse events will be collected from the patients.


Condition Intervention Phase
Stroke
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: 68Ga-BNOTA-PRGD2 PET/CT in Evaluation of Angiogenesis Following Stroke

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

Primary Outcome Measures:
  • Visual and semiquantitative assessment (Standardized Uptake Values = SUVs) of cerebral infarction region, SUV ratios (SUVinfarction/SUV contralateral) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physicians. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of suspicious region in the stroke area and the SUV ratios (SUVinfarction/SUV contralateral) will be measured.


Secondary Outcome Measures:
  • Adverse events collection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Adverse events within 5 days after the injection and PET/CT scanning will be collected and assessed.


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brain 68Ga-BNOTA-PRGD2
We will perform brain 68Ga-BNOTA-PRGD2 PET/CT on stroke patients to determine its value.
Drug: 68Ga-BNOTA-PRGD2
Intravenous injection of one dosage of 111MBq 68Ga-BNOTA-PRGD2 solution. Tracer doses of 68Ga-BNOTA-PRGD2 will be used to image angiogenesis of cerebral infarction areas 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 this receptor family and expressed preferentially on regenerative vascular endothelial cells, but not or very low 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 cerebrovascular repair processes after stroke.

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) to monitor the angiogenesis in clinical Oncology and Cardiology. In Neurology, angiogenesis imaging based on integrin αvβ3 receptor has not been found in clinical trials, but preclinical animal studies showed it had great potential for clinical translation. 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. As a representative, 68Ga-BNOTA-PRGD2 could be easily prepared and exhibited excellent in vivo behavior in animal models and also tumor or myocardial infarction patients. No adverse reactions are observed in animal models or patients to date.

For the further interests in clinical translation of 68Ga-BNOTA-PRGD2, an open-label brain PET/CT study was designed to investigate diagnostic performance of 68Ga-BNOTA-PRGD2 in stroke patients in convalescence. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 ( ≤ 40 µg BNOTA-PRGD2) will be intravenously injected into the patients. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of brain 18F-FDG PET/CT, enhanced brain MRI or CT, and any adverse events will be collected from the patients.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

stroke patients in convalescence:

  • Males and females, ≥30 years old
  • Confirmed cerebral infarction diagnosis
  • With brain CT or MRI scans

Exclusion Criteria:

  • Have cerebral tumors or other kinds of cerebral diseases
  • 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: NCT01656785

Contacts
Contact: Zhaohui Zhu, MD, PhD 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, PhD    86-10-13611093752    zzh_1969@yahoo.com.cn   
Contact: Chenxi Wu, MD    86-10-15911068700    cxwu2011@yahoo.com.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Zhaohui Zhu, MD, PhD Department of Nuclear Medicine, Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01656785     History of Changes
Other Study ID Numbers: PUMCHNM004
Study First Received: August 1, 2012
Last Updated: September 8, 2013
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
stroke
cerebrovascular disease
angiogenesis imaging
68Ga-BNOTA-PRGD2
PET/CT

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 30, 2014