Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown

Early Phase 1

Conditions

Lung Cancer

Neuroendocrine Neoplasm

Treatments

Drug: 68Ga-NOTA-3P-TATE-RGD

Study type

Interventional

Funder types

Other

Identifiers

NCT02817945

PUMCHNM13

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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