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Trial Title:
68Ga-HA-DOTATATE PET/CT in Adults With Neuroendocrine Tumors
NCT ID:
NCT05673031
Condition:
Neuroendocrine Tumors (NET)
Conditions: Official terms:
Neuroendocrine Tumors
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
68Ga-HA-DOTATATE PET/CT imaging
Description:
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.
Arm group label:
68Ga-HA-DOTATATE
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.
Criteria for eligibility:
Study pop:
Clinically suspected (patients presenting with symptom(s) suggestive of carcinoid
syndrome or biochemically suggestive of Neuroendocrine Tumor) or Biopsy proven
Neuroendocrine Tumor. Patients greater than 18 years of age who are able to follow
instructions and provide written consent to participate in study.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Foothills Medical Center 1403 29 St NW
Address:
City:
Calgary
Zip:
T2N 2T9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Denise Chan, MD
Phone:
4039441252
Email:
denise.chan@albertahealthservices.ca
Contact backup:
Last name:
Kirstie Lithgow, MD
Phone:
403-388-6301
Email:
kclithgo@ucalgary.ca
Investigator:
Last name:
Vincent Bouvet, PhD
Email:
Principal Investigator
Start date:
February 1, 2023
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Alberta Health services
Agency class:
Other
Source:
Alberta Health services
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673031
