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NCT Number: NCT06632860

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

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.

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Key information

Conditions

Iodine-resistant Thyroid Cancer Central Nervous System Neoplasms Meningeal Neoplasms Meningioma NETs Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010100, China

Location status: Recruiting

Location contact

Zhaohui Zhu, MD

CONTACT

[email protected]

86-13611093752

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

68Ga-TATE-RGD

Drug

Intravenous injection of 68Ga-TATE-RGD with the dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg. Tracer doses will be used to image lesions of by dual-targeted postive cancers PET/CT.

18-FDG

Drug

Intravenous injection of 18F-FDG with the dosage of 1.8-2.2 MBq(0.12-0.15mCi/kg). Tracer doses will be used to lesions therapy of dual-targeted postive cancers by SPECT/CT.

Primary outcomes

  1. Tumor detection rate

    Time frame: through study completion, an average of half-year

    comparing the number of tumor detected by 68Ga-TATE-RGD and18F-FDG PET/CT

Secondary outcomes

  1. standardized uptake value (SUV) of tumor

    Time frame: through study completion, an average of half-year

    comparing the SUVmax of tumor derived from 68Ga-TATE-RGD and 18F-FDG PET/CT

Study contacts

Contact information is provided by the study sponsor or research team.

Zhaohui Zhu

CONTACT

[email protected]

86-13611093752

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

a Novel Dual-Targeting Molecular Probe TATE-RGD for the Diagnostic Integration of SSTR2 and αvβ3 Positive Tumors

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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