- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02747290
68Ga-NOTA-BBN-RGD PET/CT in Prostate Cancer Patients
April 19, 2016 updated by: Peking Union Medical College Hospital
Safety and Diagnostic Performance of 68Gallium-labeled NOTA-BBN-RGD PET/CT in Prostate Cancer Patients
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in prostate cancer patients.
A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be injected intravenously.
Visual and semiquantitative method will be used to assess the PET/CT images.
Study Overview
Detailed Description
Both GRPR and integrin αvβ3 are overexpressed in neoplastic cells of human prostate cancer.
To target both receptors, a heterodimeric peptide BBN-RGD was synthesized from bombesin(7-14) and c(RGDyK) through a glutamate linker and then labeled with 68Ga.
An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-BBN-RGD and diagnostic performance of 68Ga-NOTA-BBN-RGD PET/CT in patients with primary and/or metastasis prostate cancer.
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 Contact
- Name: Zhaohui Zhu, MD.PhD.
- Phone Number: +86 10 69154196
- Email: 13611093752@163.com
Study Contact Backup
- Name: Jingjing Zhang, MD.PhD.
- Phone Number: +86 10 69155513
- Email: zhangjingjingtag@163.com
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Jingjing Zhang, MD.
- Phone Number: +86 10 69155513
- Email: zhangjingjingtag@163.com
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Must be able to provide a written informed consent, needle biopsy diagnosed as prostate cancer, have undergone whole body bone scan, able to provide basic information and sign the written informed consent.
Exclusion Criteria:
- The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.
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-BBN-RGD PET/CT
The patients were injected with 111-148 MBq of 68Ga-NOTA-BBN-RGD in one dose intravenously and underwent PET/CT scan 15-30 min later.
|
68Ga-NOTA-BBN-RGD were injected into the patients before the PET/CT scans
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate cancer
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 prostate cancer 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, MD., 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
July 1, 2014
Primary Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
April 19, 2016
First Submitted That Met QC Criteria
April 19, 2016
First Posted (Estimate)
April 21, 2016
Study Record Updates
Last Update Posted (Estimate)
April 21, 2016
Last Update Submitted That Met QC Criteria
April 19, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PUMCHNM011
- ZIAEB000073 (U.S. NIH Grant/Contract)
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.
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