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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 4/7/2026 | Other Identifier | UW Madison | |
| SMPH/RADIOLOGY/RADIOLOGY | Other Identifier | UW Madison |
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The goal of this research is to determine if DetectnetTM PET/CT can be used to make Lutathera therapy safer for patients with neuroendocrine cancer.
Participants will:
The goal of this research study is to determine if DetectnetTM PET/CT scanning over several days can be used to deliver Lutathera in a safer manner.
In this research, participants will be asked to complete a screening phase and possibly a dosimetry phase. The screening phase will require 2 visits. The dosimetry phase will also require 3 research visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated with Lutathera | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT) | Device | SPECT/CT will be performed after first cycle of Lutathera® treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare pre-therapy and post-therapy voxel-based dosimetry estimates | Absorbed doses to organs will be estimated using radiation dosimetry methods based on both multi-timepoint PET and multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between PET-based dosimetry and SPECT-based dosimetry. Using SPECT-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare PET-based dose estimates to SPECT-based estimates. Mean bias and 95% confidence intervals will be calculated. | Baseline and 120 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Absorbed radiation doses | Absorbed radiation doses from 177Lu-DOTATATE in organs will be summarized with descriptive statistics. | 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose |
| Absorbed radiation doses of 64Cu-DOTATATE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Changhee Lee, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Madison | Wisconsin | 53705 | United States |
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| Photon Emission Tomography / CT (PET/CT) | Device | PET/CT will be performed after 64Cu-DOTATATE and Lutathera® treatment |
|
| 64Cu-Dotatate | Drug | Standard of care administration of radioactive drug for PET/CT |
|
|
| 177Lu-Dotatate | Drug | Standard of care administration of radioactive drug for PET/CT and SPECT/CT |
|
|
Absorbed radiation doses of 177Lu-DOTATATE in organs using 64Cu-DOTATATE as an imagining surrogate will be summarized with descriptive statistics.
| 1 hour post-dose, 4 hours post-dose, 48 hours post-dose, 120 hours post-dose |
| Compare 3D voxel-based versus model based dosimetry in participants receiving 177Lu_DOTATATE | Absorbed doses to organs will be estimated using radiation dosimetry methods based on multi-timepoint SPECT imaging. Mean dose estimates in units of Gy to the index tumor(s) and dose limiting organs (kidneys and bone marrow) will be compared between 3D voxel-based and model-based dosimetry methods. Using 3D voxel-based dosimetry as the gold standard truth, Bland-Altman analysis will be performed for each organ/tumor to compare 3D voxel-based to model-based methods. Mean bias and 95% confidence intervals will be calculated. | Baseline and 120 hours post-dose |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D015899 | Tomography, Emission-Computed, Single-Photon |
| D014057 | Tomography, X-Ray Computed |
| D000072098 | Single Photon Emission Computed Tomography Computed Tomography |
| D000072078 | Positron Emission Tomography Computed Tomography |
| C575629 | 64Cu-DOTATATE |
| C447941 | lutetium Lu 177 dotatate |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D011856 | Radiographic Image Enhancement |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D064847 | Multimodal Imaging |
| D049268 | Positron-Emission Tomography |
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