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Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02817945
Enrollment
100
Registered
2016-06-29
Start date
2016-06-01
Completion date
2022-12-31
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Neuroendocrine Neoplasm

Keywords

TATE-RGD, SSTR2, integrin αvβ3

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.

Interventions

DRUG68Ga-NOTA-3P-TATE-RGD

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

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm1 yearThe 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.

Countries

China

Contacts

Primary ContactZhaohui Zhu, MD
13611093752@163.com+8613611093752
Backup ContactShaobo Yao, PhD
yaoshaobo008@163.com+8618301511895

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026