NCT05673031

68Ga-HA-DOTATATE PET/CT in Adults With Neuroendocrine Tumors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Alberta Health services · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

To determine if 68Ga-HA-DOTATATE PET/CT imaging is effective at diagnosing somatostatin positive tumors compared to conventional imaging \[including CT, MRI, 111 In-pentetreotide Scans, 18F-FDG PET/CT, as available\]

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.

Conditions

• Neuroendocrine Tumors (NET)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-01-05
• Last updated: 2023-01-05

Locations

1 site across 1 country: Canada