Back to results68Ga-NOTA-BBN-RGD PET/CT in Prostate Cancer Patients
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NOTA-BBN-RGD
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring BBN-RGD, PET, integrin αvβ3, GRPR
Eligibility Criteria
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.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-NOTA-BBN-RGD PET/CT
Arm Description
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.
Outcomes
Primary Outcome Measures
Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate cancer
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.
Secondary Outcome Measures
Adverse events collection
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.
Full Information
NCT ID
NCT02747290
First Posted
April 19, 2016
Last Updated
April 19, 2016
Sponsor
Peking Union Medical College Hospital
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
1. Study Identification
Unique Protocol Identification Number
NCT02747290
Brief Title
68Ga-NOTA-BBN-RGD PET/CT in Prostate Cancer Patients
Official Title
Safety and Diagnostic Performance of 68Gallium-labeled NOTA-BBN-RGD PET/CT in Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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-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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
BBN-RGD, PET, integrin αvβ3, GRPR
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-NOTA-BBN-RGD PET/CT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
68Ga-NOTA-BBN-RGD
Intervention Description
68Ga-NOTA-BBN-RGD were injected into the patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate cancer
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.
Time Frame
1 week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu, MD.PhD.
Phone
+86 10 69154196
Email
13611093752@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jingjing Zhang, MD.PhD.
Phone
+86 10 69155513
Email
zhangjingjingtag@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Li, MD.
Organizational Affiliation
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingjing Zhang, MD.
Phone
+86 10 69155513
Email
zhangjingjingtag@163.com
12. IPD Sharing Statement
Learn more about this trial
68Ga-NOTA-BBN-RGD PET/CT in Prostate Cancer Patients
We'll reach out to this number within 24 hrs