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

A

Alberta Health services

Status

Enrolling

Conditions

Neuroendocrine Tumors (NET)

Treatments

Diagnostic Test: 68Ga-HA-DOTATATE PET/CT imaging

Study type

Observational

Funder types

Other

Identifiers

NCT05673031
NM-CRS-002

Details and patient eligibility

About

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]

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

  1. Nursing or pregnant females.
  2. Age less than 18 years.
  3. Surgery in the area of interest within the preceding 2 months.

Trial design

500 participants in 1 patient group

68Ga-HA-DOTATATE
Description:
68Ga-HA-DOTATATE Intravenous injection of 100-250 MBq 68Ga-HA-DOTATATE
Treatment:
Diagnostic Test: 68Ga-HA-DOTATATE PET/CT imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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