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

July 8, 2025 updated by: Zhaohui Zhu, Peking Union Medical College Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 010100
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of half-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of half-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 20, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-TR-DTC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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