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| Name | Class |
|---|---|
| Advanced Accelerator Applications | INDUSTRY |
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The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving PET scan | Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTATATE | Drug | The NETspot kit is 2 vials, Vial 1 contains 40 mcg dotatate, 5 mcg 1,10phenanthroline; 6mcg gentisic acid and 20 mg mannitol. Vial 2 contains 60 mg formic acid, 56.5 mg sodium hydroxide and water for injection |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Uniformly Positive 68Ga-dotatate PET | Percentage of participants with uniformly positive 68Ga-dotatate PET (positivity defined as SUV uptake > liver for all tumors at least 1cm in size). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging. | Up to 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with No Uptake to Very High Uptake on PET | Percentage of Participants with no uptake, heterogeneous uptake (tumors showing substantial differences in Somatostatin receptor [SSTR] uptake), low uptake (max SUV≤ liver), moderate uptake (liver<max SUV ≤2x liver, high uptake (max SUV > 2x liver), very high uptake (max SUV≥ kidney or spleen). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of Moffitt Cancer Center's GI Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Strosberg, MD | H Lee Moffitt Cancer & Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Lee Moffitt Cancer & Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C513399 | gallium Ga 68 dotatate |
| D049268 | Positron-Emission Tomography |
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Positron Emission Tomography (PET) Scan | Diagnostic Test | PET scan is an imaging test using radioactive tracers. |
|
| Up to 10 months |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |