68Ga-NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas
Safety and Diagnostic Performance of 68Gallium-labeled NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas
2 other identifiers
interventional
30
1 country
1
Brief Summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jan 2015
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 2, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 7, 2017
March 1, 2015
2.9 years
August 2, 2015
April 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Standardized uptake value of 68Ga-NOTA-Aca-BBN(7-14) in primary glioma
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in primary glioma will be measured.
1 year
Secondary Outcomes (1)
Adverse events collection
1 week
Study Arms (1)
68Ga-NOTA-Aca-BBN(7-14) PET/CT
EXPERIMENTALThe patients were injected with 111-148 MBq of 68Ga-NOTA-Aca-BBN(7-14) in one dose intravenously and underwent PET/CT scan 30 min later.
Interventions
68Ga-NOTA-Aca-BBN(7-14) were injected into the patients before the PET/CT scans
Eligibility Criteria
You may qualify if:
- Must be able to provide a written informed consent
- Clinically based and magnetic resonance imaging (MRI)-based suspected newly diagnosed primary glioma.
- The tumor will be surgically removed and histological diagnosis will be available.
You may not qualify if:
- Females planning to bear a child recently or with childbearing potential；
- Known severe allergy or hypersensitivity to IV radiographic contrast；
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fang Li, Dr.
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Central Study Contacts
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
August 2, 2015
First Posted
August 13, 2015
Study Start
January 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 7, 2017
Record last verified: 2015-03
Data Sharing
- IPD Sharing
- Will not share