Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled anti-ED-B mAbs SPECT imaging in patients with ED-B positive solid tumors.
After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 177Lu-labeled anti-ED-B mAbs and will undergo SPECT/CT scanning to determine uptake of 177Lu-labeled anti-ED-B mAbs in tumor lesions and normal tissues and organs.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 177Lu-Anti-ED-B mAbs | Experimental | Patients will receive a tracer (5 mg, IV) dose of 177Lu (10 mCi) labeled anti-ED-B mAbs(177Lu-B5-IgG4) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-B5-IgG4 | Drug | 177Lu-B5-IgG4 injection followed by SPECT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of tissue distribution of 177Lu-Anti-ED-B mAbs(B5-IgG4) | Biodistribution of 177Lu-Anti-ED-B mAbs(B5-IgG4) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 177Lu-SPECT scans will be reported. | 1 year |
| Dosimetry estimates of 177Lu-Anti-ED-B mAbs(B5-IgG4) | Absorbed dose (radioactive uptake) estimates for different organs and tissues calculated with the AUCs and the OLINDA/EXM dosimetry program will be obtained and reported. | 1 year |
| Incidence of Treatment-Emergent Adverse Events | Safety will be assessed by evaluation of incidence of adverse events. | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunjing Yu | Contact | 15312238622 | ycj_wxd1978@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | 214000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided