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Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging

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ClinicalTrials.gov Identifier: NCT02817945
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: 68Ga-NOTA-3P-TATE-RGD Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-NOTA-3P-TATE-RGD for Dual Somatostatin Receptor and Integrin αvβ3 PET/CT Imaging of Lung Cancer and Neuroendocrine Neoplams
Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 68Ga-NOTA-3P-TATE-RGD PET/CT
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.
Drug: 68Ga-NOTA-3P-TATE-RGD
68Ga-NOTA-3P-TATE-RGD were injected into the patients before the PET/CT scans




Primary Outcome Measures :
  1. Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung 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 breast cancer will be measured.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817945


Contacts
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Contact: Zhaohui Zhu, MD +8613611093752 13611093752@163.com
Contact: Shaobo Yao, PhD +8618301511895 yaoshaobo008@163.com

Locations
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China, Beijing
Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College Recruiting
Beijing, Beijing, China, 100730
Contact: Zhaohui Zhu, MD    +8613611093752    13611093752@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02817945    
Other Study ID Numbers: PUMCHNM13
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Keywords provided by Peking Union Medical College Hospital:
TATE-RGD
SSTR2
integrin αvβ3
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases