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

Early Phase 1

Recruiting

• Conditions: Iodine-resistant Thyroid Cancer; Meningioma; NETs
• Interventions: Drug: 68Ga-TATE-RGD; Drug: 18-FDG

• Registration Number: NCT06632860
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: 68Ga-TATE-RGD PET/ CT scan	68Ga-TATE-RGD	About 30 patients with positive expression of somatostatin receptor SSTR2 and integrin receptor αvβ3 were included for PET imaging.
Experimental: 68Ga-TATE-RGD PET/ CT scan	18-FDG	About 30 patients with positive expression of somatostatin receptor SSTR2 and integrin receptor αvβ3 were included for PET imaging.

Primary Outcome Measures

Name	Time	Method
Tumor detection rate	through study completion, an average of half-year	comparing the number of tumor detected by 68Ga-TATE-RGD and18F-FDG PET/CT

Secondary Outcome Measures

Name	Time	Method
standardized uptake value (SUV) of tumor	through study completion, an average of half-year	comparing the SUVmax of tumor derived from 68Ga-TATE-RGD and 18F-FDG PET/CT

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China