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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital

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.