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To test the feasibility of theranostic targeting the PSMA receptor in STS patients by Ga-68-PSMA-11 PET/CT and Lu-177-ITG-PSMA-1 treat-ment with special emphasis on vascular disruption using a translational approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Ga-68-PSMA-11 PET/CT patients treated by Lu-177-ITG-PSMA-1 | Experimental | Positive Ga-68-PSMA-11 PET/CT prior to two cycles of Lu-177-ITG-PSMA-1 i scheduled six weeks apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68-PSMA-11 PET/CT | Drug | Ga-68-PSMA-11 PET/CT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| imaging result obtained by Ga-68-PSMA-11 PET/CT | four weeks after the second cycle of Lu-177-ITG-PSMA-1 treatment, compared to base-line |
| Measure | Description | Time Frame |
|---|---|---|
| SUVmax and radiological changes using PSMA - PET/CT | SUVmax and radiological changes using PSMA - PET/CT using advanced radiological assessment including CHOI criteria to as-sess the necrosis one month after end of second cycle | four weeks after the second cycle of Lu-177-ITG-PSMA-1 treatment, compared to base-line. |
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Inclusion Criteria:
Exclusion Criteria:
Platelets < 75,000/µL. Leukocytes < 2,500/µL Haemoglobin < 80 g/L. • Disturbance of liver function with: Total bilirubin > 2 times the upper limit of the norm ASAT/ALAT > 3 times the upper limit without the presence of liver metastases ASAT/ALAT > 5 times the upper limit in the presence of liver metastases
• Hypersensitivity to any of the ingredients of the injectable product
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| Name | Affiliation | Role |
|---|---|---|
| John O Prior, PhD MD | Centre Hospitalier Universitaire Vaudois - Lausanne University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Lu-177-ITG-PSMA-1 | Drug | Lu-177-ITG-PSMA-1 treatment |
|
| Tumor evaluation using contrast enhanced computed tomography (ceCT) |
Tumor evaluation using contrast enhanced computed tomography (ceCT) using RECIST v1.1 (change in tumor size in mm) |
| four weeks after the second cycle of Lu-177-ITG-PSMA-1 treatment, compared to base-line. |