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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06632860
Enrollment
40
Registered
2024-10-09
Start date
2024-08-01
Completion date
2025-12-30
Last updated
2025-07-09

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

Conditions

Iodine-resistant Thyroid Cancer, Meningioma, NETs

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.

Interventions

DRUG68Ga-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.

DRUG18-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.

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 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Tumor detection ratethrough study completion, an average of half-yearcomparing the number of tumor detected by 68Ga-TATE-RGD and18F-FDG PET/CT

Secondary

MeasureTime frameDescription
standardized uptake value (SUV) of tumorthrough study completion, an average of half-yearcomparing the SUVmax of tumor derived from 68Ga-TATE-RGD and 18F-FDG PET/CT

Countries

China

Contacts

Primary ContactZhaohui Zhu
13611093752@163.com86-13611093752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026