Recruiting

68Ga-HA-DOTATATE

Sponsor:

Alberta Health services

Code:

NCT05673031

Conditions

Neuroendocrine Tumors (NET)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

68Ga-HA-DOTATATE PET/CT imaging

Study Details

Brief summary:

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

Conditions

Neuroendocrine Tumors (NET)

Study ID

NCT05673031

Start date

Feb 1, 2023

Status verified date

Jan, 2023

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

68Ga-HA-DOTATATE

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

Interventions

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 measure

  • 68Ga-HA-DOTATATE PET/CT imaging [ Time Frame: 5 years ]

Central Contacts and Locations

Locations

Foothills Medical Center 1403 29 St NW

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Denise Chan, MD

4039441252denise.chan@albertahealthservices.ca

Kirstie Lithgow, MD

403-388-6301kclithgo@ucalgary.ca

Principal Investigator:

Vincent Bouvet, PhD

More Information

Sponsor

Alberta Health services

Last update posted

Jan 5, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alberta Health services on 2023-01-05.