Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging
Primary Purpose
Lung Cancer, Neuroendocrine Neoplasm
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NOTA-3P-TATE-RGD
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring TATE-RGD, SSTR2, integrin αvβ3
Eligibility Criteria
Inclusion Criteria:
- Neoplasm identified by X-ray, ultrasound or MRI as lung cancer or neuroendocrine tumors
- 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 Hospitall, Chinese Academy of Medical Science and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-NOTA-3P-TATE-RGD PET/CT
Arm Description
The patients were injected with 111-185 MBq of 68Ga-NOTA-3P-TATE-RGD in one dose intravenously and underwent PET/CT scan 45-60 min later.
Outcomes
Primary Outcome Measures
Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm
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
NCT02817945
First Posted
June 27, 2016
Last Updated
March 30, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02817945
Brief Title
Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging
Official Title
68Ga-NOTA-3P-TATE-RGD for Dual Somatostatin Receptor and Integrin αvβ3 PET/CT Imaging of Lung Cancer and Neuroendocrine Neoplams
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
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 evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in lung cancer patients and neuroendocrine neoplam patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3P-TATE-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Detailed Description
The number of somatostatin receptors may be greatly up-regulated in the cells of a variety of tumor including carcinoids, gastrinomas, paragangliomas, small cell lung cancer and non-small cell lung cancer. Octreotide is an eight amino acid cyclic peptide that preserves a four amino acid motif (Phe-Trp-Lys-Thr) that is critical for the biological activity of somatostatin (SSTR). On the other hand, the RGD moiety binds with integrin αvβ3, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human tumor. To target both receptors, a heterodimeric peptide TATE-RGD was synthesized from TATE and RGD 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-3PTATE-RGD and diagnostic performance of 68Ga-NOTA-3PTATE-RGD PET/CT in evaluation of lung cancer and neuroendocrine neoplams.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Neuroendocrine Neoplasm
Keywords
TATE-RGD, SSTR2, integrin αvβ3
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
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-NOTA-3P-TATE-RGD PET/CT
Arm Type
Experimental
Arm Description
The patients were injected with 111-185 MBq of 68Ga-NOTA-3P-TATE-RGD in one dose intravenously and underwent PET/CT scan 45-60 min later.
Intervention Type
Drug
Intervention Name(s)
68Ga-NOTA-3P-TATE-RGD
Intervention Description
68Ga-NOTA-3P-TATE-RGD were injected into the patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm
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
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Neoplasm identified by X-ray, ultrasound or MRI as lung cancer or neuroendocrine tumors
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
Phone
+8613611093752
Email
13611093752@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shaobo Yao, PhD
Phone
+8618301511895
Email
yaoshaobo008@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospitall, 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
Phone
+8613611093752
Email
13611093752@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
35657429
Citation
Jiang Y, Liu Q, Wang G, Sui H, Wang R, Wang J, Zhu Z. A prospective head-to-head comparison of 68 Ga-NOTA-3P-TATE-RGD and 68 Ga-DOTATATE in patients with gastroenteropancreatic neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4218-4227. doi: 10.1007/s00259-022-05852-3. Epub 2022 Jun 3.
Results Reference
derived
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Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging
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