Dual Integrin αvβ3 and GRPR Targeting PET Imaging in Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NOTA-BBN-RGD
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring BBN-RGD, GRPR, integrin αvβ3
Eligibility Criteria
Inclusion Criteria:
- Neoplasm identified by X-ray, ultrasound or MRI as breast cancer
- To provide basic information and sign the written informed consent.
Exclusion Criteria:
- Consisted of conditions of mental illness;
- Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
- Severe allergy or hypersensitivity to IV radiographic contrast
- Claustrophobia to accept the PET/CT scanning
- Pregnancy or breast feeding
Sites / Locations
- Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical CollegeRecruiting
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 breast 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 breast cancer will be measured.
Secondary Outcome Measures
Full Information
NCT ID
NCT02749019
First Posted
April 20, 2016
Last Updated
April 21, 2016
Sponsor
Peking Union Medical College Hospital
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
1. Study Identification
Unique Protocol Identification Number
NCT02749019
Brief Title
Dual Integrin αvβ3 and GRPR Targeting PET Imaging in Breast Cancer Patients
Official Title
68Ga-NOTA-BBN-RGD PET/CT in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2018 (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 breast 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
Gastrin-releasing peptide receptor (GRPR) is a member of the G protein-coupled receptor family of bombesin receptors, which is over-expressed in various types of cancer cells, including prostate cancer, breast cancer, colorectal cancer, pancreatic cancer, glioma, lung cancer, ovarian cancers, endometrial cancers, renal cell cancer and gastrointestinal stromal tumors. 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 GRPR. On the other hand, the RGD moiety binds with integrin αvβ3 receptor, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human breast 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 breast cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
BBN-RGD, GRPR, integrin αvβ3
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (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 breast 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 breast cancer will be measured.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Neoplasm identified by X-ray, ultrasound or MRI as breast cancer
To provide basic information and sign the written informed consent.
Exclusion Criteria:
Consisted of conditions of mental illness;
Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
Severe allergy or hypersensitivity to IV radiographic contrast
Claustrophobia to accept the PET/CT scanning
Pregnancy or breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu, MD. PhD.
Phone
+86 10 69154196
Email
zhuzhh@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jingjing Zhang, MD. PhD
Phone
+86 10 69155513
Email
zhangjingjing@pumch.cn
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD. PhD.
Phone
+86 10 69154196
Email
zhuzhh@pumch.cn
12. IPD Sharing Statement
Learn more about this trial
Dual Integrin αvβ3 and GRPR Targeting PET Imaging in Breast Cancer Patients
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