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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
October 7, 2024
CompletedFirst Posted
Study publicly available on registry
October 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedJuly 9, 2025
October 1, 2024
1.4 years
October 7, 2024
July 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Tumor detection rate
comparing the number of tumor detected by 68Ga-TATE-RGD and18F-FDG PET/CT
through study completion, an average of half-year
Secondary Outcomes (1)
standardized uptake value (SUV) of tumor
through study completion, an average of half-year
Study Arms (1)
Experimental: 68Ga-TATE-RGD PET/ CT scan
EXPERIMENTALAbout 30 patients with positive expression of somatostatin receptor SSTR2 and integrin receptor αvβ3 were included for PET imaging.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- histologically confirmed various cancer patients;
- Ga-TATE-RGD and 18F-FDG PET/CT within a week;
- signed written consent.
You may not qualify if:
- known allergy against TATE-RGD;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 010100, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof.
Study Record Dates
First Submitted
October 7, 2024
First Posted
October 9, 2024
Study Start
August 1, 2024
Primary Completion
December 20, 2025
Study Completion
December 30, 2025
Last Updated
July 9, 2025
Record last verified: 2024-10