Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging

Lung Cancer Clinical Trial

Official title:

68Ga-NOTA-3P-TATE-RGD for Dual Somatostatin Receptor and Integrin αvβ3 PET/CT Imaging of Lung Cancer and Neuroendocrine Neoplams

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817945
• Other study ID #: PUMCHNM13
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD
• Phone: +8613611093752
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 µ?) 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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Neuroendocrine Neoplasm
• Neuroendocrine Tumors

Intervention

Drug:
• 68Ga-NOTA-3P-TATE-RGD
68Ga-NOTA-3P-TATE-RGD were injected into the patients before the PET/CT scans

Locations

Country	Name	City	State
China	Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year