FAP- Expressing Positive Tumors, RGD- Expressing Positive Tumors
Conditions
Brief summary
FAP and RGD are overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-FAPI-RGD--a new dual-targeted 177Lu therapeutic drug for the first time in the world.
Detailed description
Fibroblast activation protein (FAP) and RGD are serine peptidase on the surface of tumor associated fibroblasts. It has special biological characteristics and stable genome. They are usually not expressed or expressed at a low level in the resting tissues of normal adults, but it is highly expressed in diseases related to tissue repair and matrix reconstruction,Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors and used to 177Lu PRRT. We'll try to assess the safety and therapeutic response to 177Lu-FAPI-RGD in patients with metastatic tumors in human.
Interventions
DRUG68Ga-FAPI-RGD for PET / CT scan and 177Lu-FAPI-RGD for therapy
Patients with positive results were screened with 68Ga-FAPI PET / CT, and 2.22-3.33GBq(60mci-100mCi) 177Lu-FAPI-RGD was injected intravenously for therapy after contraindications were excluded and informed consent was signed.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* confirmed treated or untreated metastatic tumors patients; * 68Ga-FAPI PET/CT and 18F-FDG PET/CT within two weeks; * signed written consent.
Exclusion criteria
* pregnancy; * breastfeeding; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tandarStandardized uptake value of 177Lu-TATE-RGD in normal organs and tumors. | through study completion, an average of half-year | The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and tumors will be measured. |
| Adverse events collection | through study completion, an average of 2 months | Adverse events within 2 months after the injection and scanning of patients will be followed and assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SUVmax, SUVmean, lesion-based analysis | through study completion, an average of 1 year | Sensitivity and Specificity of 68Ga-FAPI PET/CT for metastatic tumors in comparison with 18F-FDG PET/CT, including some semi-quantative quota for lesion-based analysis, such as SUVmax, SUVmean |
Countries
China
Contacts
Primary ContactZhaohui Zhu, MD
Outcome results
None listed