68Ga-NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas
April 5, 2017 updated by: Peking Union Medical College Hospital
Safety and Diagnostic Performance of 68Gallium-labeled NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas
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.
Study Overview
Detailed Description
Non-invasive imaging evaluation of GRPR expression would be of great help in drug development, patient stratification and therapeutic response monitoring.
Various GRPR targeting imaging probes have been develop to meet the purpose.
Bombesin (BBN) is an amphibian homolog of mammalian gastrin-releasing peptide (GRP).
BBN(7-14), with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), after being labeled with various radionuclides.
Multiple preclinical studies have demonstrated receptor-specific accumulation of the tracers in GRPR positive tumors.
For interests in clinical translation of 68Ga-NOTA-Aca-BBN(7-14), an open-label dynamic whole-body PET/ CT study was designed to investigate the safety and diagnostic performance of 68Ga-NOTA-Aca-BBN(7-14) in patients with glioma.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Jingjing Zhang, Dr.
- Phone Number: +86 15101033017
- Email: zhangjingjingtag@163.com
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Principal Investigator:
- Fang Li, Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 68Ga-NOTA-Aca-BBN(7-14) PET/CT
The 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.
|
68Ga-NOTA-Aca-BBN(7-14) were injected into the patients before the PET/CT scans
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Standardized uptake value of 68Ga-NOTA-Aca-BBN(7-14) in primary glioma
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events collection
Time Frame: 1 week
|
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Fang Li, Dr., Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
August 2, 2015
First Submitted That Met QC Criteria
August 11, 2015
First Posted (Estimate)
August 13, 2015
Study Record Updates
Last Update Posted (Actual)
April 7, 2017
Last Update Submitted That Met QC Criteria
April 5, 2017
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCHNM11
- ZIAEB000073 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.