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

Recruiting

Phase Early 1 Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • 68Ga-BNOTA-PRGD2 Drug
    Other Names: 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2
    Intervention Desc: 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)
    ARM 1: Kind: Experimental
    Label: Brain 68Ga-BNOTA-PRGD2
    Description: We will perform brain 68Ga-BNOTA-PRGD2 PET/CT on stroke patients to determine its value.

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Visual and semiquantitative assessment (Standardized Uptake Values = SUVs) of cerebral infarction region, SUV ratios (SUVinfarction/SUV contralateral) 1 year No
Secondary Adverse events collection 1 year Yes

Sponsors