68Ga-HA-DOTATATE PET/CT in Adults With Neuroendocrine Tumors
Study Details
Study Description
Brief Summary
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]
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 68Ga-HA-DOTATATE 68Ga-HA-DOTATATE Intravenous injection of 100-250 MBq 68Ga-HA-DOTATATE |
Diagnostic Test: 68Ga-HA-DOTATATE PET/CT imaging
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.
After the 68Ga-HA-DOTATATE acquisition is complete, a CT scan will be performed for attenuation correction and localization in the same in line gantry without patient movement between the two scans.
The results of the 68Ga-HA-DOTATATE PET/CT will be compared to any prior imaging and pathologic results.
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Outcome Measures
Primary Outcome Measures
- 68Ga-HA-DOTATATE PET/CT imaging [5 years]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female. If female of child-bearing potential and outside of the window of 10 days since the last menstrual period, a negative pregnancy test will be required.
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Age greater than or equal to 18 years.
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Able and willing to follow instructions and comply with the protocol.
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Provide written informed consent prior to participation in the study.
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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
Exclusion Criteria:
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Nursing or pregnant females.
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Age less than 18 years.
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Surgery in the area of interest within the preceding 2 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Foothills Medical Center 1403 29 St NW | Calgary | Alberta | Canada | T2N 2T9 |
Sponsors and Collaborators
- Alberta Health services
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NM-CRS-002