68Ga-HA-DOTATATE PET/CT in Adults With Neuroendocrine Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-HA-DOTATATE PET/CT imaging.
- Who it may be relevant to
- Registry conditions: Neuroendocrine Tumors (NET). Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- 68Ga-HA-DOTATATE PET/CT imaging [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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.
- Age greater than or equal to 18 years.
- Able and willing to follow instructions and comply with the protocol.
- Provide written informed consent prior to participation in the study.
- Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven Neuroendocrine Tumor
Exclusion criteria
- Nursing or pregnant females.
- Age less than 18 years.
- Surgery in the area of interest within the preceding 2 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Canada · 1 center
- Foothills Medical Center 1403 29 St NW — Calgary
Identifiers
NCT: NCT05673031 · NM-CRS-002