Integrin αVβ3 Positive Tumors
Conditions
Brief summary
This is an open-label, non-controlled, non-randomized study to assess the safety and measure image-based absorbed dose of 177Lu-AB-3PRGD2 in patients with Integrin αVβ3 positive tumors who will undergo radioliagnd therapy using 177Lu-AB-3PRGD2.
Detailed description
Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of Integrin αVβ3 positive tumors. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, provide an effective target for the treatment of Integrin αVβ3 positive tumors. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with single dose 1.48 GBq (40 mCi) of 177Lu-AB-3PRGD2 within one week. 1-2 ml venous blood was collected at 5min, 3h, 24h, 72h and 168h after administration to detect radioactivity count, respectively. Then monitored at 3, 24, 48, 72, 96, 120 and 168 h after 177Lu-AB-3PRGD2 administration with serial whole body planar and SPECT/CT imaging (72 or 96h). Analyze and calculate the internal radiation dose of 177Lu-AB-3PRGD2 and evaluate its therapeutic efficiency and response.
Interventions
DRUG1.48 GBq of 177Lu-AB-3PRGD2
accepted intravenous injection of 177Lu-AB-3PRGD2
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 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with clear pathological diagnosis and ineffective or progressing clinical conventional treatment; * tumor lesions with high RGD untake confirmed on 68Ga-RGD PET/CT within one week before the injection of 177Lu-AB-3PRGD2; * signed written consent.
Exclusion criteria
* the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| StandarStandardized uptake value of 177Lu-AB-3PRGD2 in normal organs and tumors. | 1 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events collection | 2 months | Adverse events within 2 months after the injection and scanning of patients will be followed and assessed. |
Countries
China
Contacts
Primary ContactZhaohui Zhu, MD
Backup ContactGuochang Wang, MD
Outcome results
None listed