A Dual-targeting Tracer TATE-RGD for the Diagnosis of SSTR- and RGD- Positive Tumors

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Early Phase 1

Conditions: NETs; Meningioma; Iodine-resistant Thyroid Cancer

Treatments: Drug: 68Ga-TATE-RGD; Drug: 18-FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT06632860

PUMCH-TR-DTC

Details and patient eligibility

About

The US FDA approved a targeted somatostatin receptor 2 imaging agent, 68Ga-DOTATATE, in 2016. It has higher uptake in small cell lung cancer, pulmonary carcinoid, and medullary thyroid cancer. Integrin αvβ3 is highly expressed in some tumor cells and new blood vessels, making it an ideal target for targeted diagnosis and treatment of tumors and tumor vessels.68Ga-labeled DOTA-TATE-RGD is a new type of tumor-specific imaging agent developed by researchers based on the above foundation, which is used for targeted diagnosis and internal radiation therapy for patients with SSTR2 and αvβ3 positive tumors.

Full description

This research has conducted extensive studies on the treatment of neuroendocrine tumors with 177Lu-EB-TATE and the treatment of FAP-expressing tumors with 177Lu-EB-FAPI. The same protocol had demonstrated 68Ga-TATE-RGD showed an increasing TBR, suggesting the tracer kinetic advantage of TATE-RGD. Compared to the single-target tracer DOTATATE, the dual-target TATE-RGD probe has a clear advantage in detecting NETs liver metastases, and it can be explored for potential therapeutic uses in future studies and used for related companion diagnostics in targeted radiolabeling therapy (RLT), which has been published in the 1st-impact factor journal European Journal of Nuclear Medicine and Medical Imaging (IF: 9.6), performing a small-dose diagnostic PET imaging with the same tracer.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• histologically confirmed various cancer patients;
• 68Ga-TATE-RGD and 18F-FDG PET/CT within a week;
• signed written consent.

Exclusion criteria

• known allergy against TATE-RGD;
• any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Experimental: 68Ga-TATE-RGD PET/ CT scan

Experimental group

Description:

About 30 patients with positive expression of somatostatin receptor SSTR2 and integrin receptor αvβ3 were included for PET imaging.

Treatment:

Drug: 18-FDG

Drug: 68Ga-TATE-RGD