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| Name | Class |
|---|---|
| Radiomedix, Inc. | INDUSTRY |
| Excel Diagnostics and Nuclear Oncology Center | OTHER |
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To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like CT scan/MRI as gold standard.
The number of lesions that could be identified clearly as single foci will be determined for each patient. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection. Because of confluence and inability to clearly delineate single liver lesions in some cases, liver metastases will be classified as 1 organ metastasis, independent of the number of liver metastases present. Lymph nodes smaller than 1 cm on CT or MRI and showing marked avidity for 68Ga- DOTATATE and 111In-penteoctreotide will be labeled as positive for disease. The presence of lesions will be confirmed by cross-sectional imaging of all patients with CT or MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-DOTATATE | Experimental | All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-DOTATATE | Drug | 68Ga-DOTATATE (3-5 mCi ±25%; 111-185 MBq) is administered as a single intravenous bolus injection in each participant. These injections were performed within 28 days after the Octreoscan. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique | We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI). | SOT within 28 days before 68Ga-DOTATATE PET/CT scan |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of Adverse Events | Adverse events will be collected from the time of 68Ga-DOTATATE injection until 48 hours post-injection visit. Adverse events will be classified using criteria for adverse events (CTCAE) Version 4. | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ebrahim Delpassand, MD | Radiomedix, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radio- Isotope Therapy of America | Houston | Texas | 77042 | United States |
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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 |
| D000072078 | Positron Emission Tomography Computed Tomography |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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|
| PET/CT | Diagnostic Test | 68Ga-DOTATATE PET images will be acquired 60 ±30 minutes after injection of 68Ga-DOTATATE. 68Ga-DOTATATE PET images were performed within 28 days after the Octreoscan. |
|
|
| 111In-pentetreotide OctreoScan | Diagnostic Test | OctreoScan™ was performed after intravenous injection of 111In-pentetreotide, a radiopharmaceutical that binds to somatostatin receptors, if the patient had not undergone such imaging as a standard of care. Subsequent planar and/or SPECT imaging was used to detect somatostatin receptor-positive lesions. |
|
| MRI | Diagnostic Test | MRI (Standard of Care) |
|
|
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |