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Trial Title:
A Dual-targeting Tracer TATE-RGD for the Diagnosis of SSTR- and RGD- Positive Tumors
NCT ID:
NCT06632860
Condition:
Iodine-resistant Thyroid Cancer
Meningioma
NETs
Conditions: Official terms:
Meningioma
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-TATE-RGD
Description:
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.
Arm group label:
Experimental: 68Ga-TATE-RGD PET/ CT scan
Intervention type:
Drug
Intervention name:
18-FDG
Description:
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.
Arm group label:
Experimental: 68Ga-TATE-RGD PET/ CT scan
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
010100
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu, MD
Phone:
86-13611093752
Email:
jialinx29@126.com
Start date:
August 1, 2024
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06632860
