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To determine if 68Ga-HA-DOTATATE PET/CT imaging is effective at diagnosing somatostatin positive tumors compared to conventional imaging [including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available]
The purpose of the current study will be to evaluate the usefulness of 68Ga-HA-DOTATATE compared to current standard anatomical imaging including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available. Specifically, we aim to assess the utility of 68Ga-HA-DOTATATE in primary workup of neuroendocrine tumours, including suspected neuroendocrine tumours that do not have a cross-sectional imaging correlate. An additional aim is to assess the role of 68Ga-HA-DOTATATE in surveillance of completely resected neuroendocrine tumours, which is a point of disagreement amongst current society guidelines . Finally, we will assess utility of 68Ga-HA-DOTATATE for localization of functioning neuroendocrine tumors including insulinoma and gastrinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-HA-DOTATATE | 68Ga-HA-DOTATATE Intravenous injection of 100-250 MBq 68Ga-HA-DOTATATE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-HA-DOTATATE PET/CT imaging | Diagnostic Test | Each patient will receive an IV injection 68Ga-HA-DOTATATE. Imaging will be conducted beginning 45-90 minutes after an injection of between 100-250 MBq 68Ga-HA-DOTATATE in patients.
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| Measure | Description | Time Frame |
|---|---|---|
| 68Ga-HA-DOTATATE PET/CT imaging | To compare 68Ga-HA-DOTATATE PET/CT imaging at identifying somatostatin positive tumors to conventional imaging [including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available]. 68Ga-HA-DOTATATE PET/CT scans will be evaluated for abnormal accumulation of 68Ga-HA-DOTATATE. Any abnormal uptake will be determined for up to 5 lesions and compared to results of standard of care imaging performed [including CT, MRI, 111 In-pentetreotide (OctreoscanTM) Scan with SPECT/CT, 18F-FDG PET/CT, as available] for presence/absence of each lesion. Comparison to any follow up 68Ga-HA-DOTATATE PET/CT Scans will also be performed (up to 5 follow up68Ga-HA-DOTATATE PET/CT Scans will be allowed). | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor. Patients greater than 18 years of age who are able to follow instructions and provide written consent to participate in study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Center 1403 29 St NW | Recruiting | Calgary | Alberta | T2N 2T9 | Canada |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D009380 | Neoplasms, Nerve Tissue |