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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2027-01-01

Brief Summary

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

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Detailed Description

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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

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Neuroendocrine Tumors (NET)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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68Ga-HA-DOTATATE

68Ga-HA-DOTATATE Intravenous injection of 100-250 MBq 68Ga-HA-DOTATATE

68Ga-HA-DOTATATE PET/CT imaging

Intervention Type 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.

* 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Age greater than or equal to 18 years.
3. Able and willing to follow instructions and comply with the protocol.
4. Provide written informed consent prior to participation in the study.
5. Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor