Recruiting
Phase 2

68Ga-HA-DOTATATE

Sponsor:

University of Alberta

Code:

NCT04888481

Conditions

Neuroendocrine Tumors

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

68Ga-HA-DOTATATE

Study Details

Brief summary:

Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In the past, 111In-octreotide imaging has been used for this purpose but it has been recently supplanted globally by SSR positron emission tomography (PET) imaging due to better image quality and higher diagnostic accuracy.

This study will assess the safety and diagnostic effectiveness of 68Ga-HA-DOTATATE produced a the Edmonton Radiopharmaceutical Centre (ERC).

Conditions

Neuroendocrine Tumors

Study ID

NCT04888481

Start date

Feb 15, 2022

Status verified date

May, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma
  • A standard clinical CT or MRI is obtained within 6 months of enrollment
  • Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker)

Exclusion Criteria:

  • Weight > 225 kg (weight limit of the PET/CT scanner)
  • Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
  • Any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation
  • Previous allergic reaction to DOTATATE or somatostatin analogues
  • Lack of intravenous access

Study Design

Enrollment

600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 68Ga-HA-DOTATATE PET/CT scan

2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging

Interventions

68Ga-HA-DOTATATE

Tracer injection

Primary outcome measure

  • Efficacy - sensitivity [ Time Frame: 1 year post-scan ]
  • Efficacy - specificity [ Time Frame: 1 year post-scan ]

Central Contacts and Locations

Central contacts

Jonathan Abele, MD

780-407-6907jabele@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

More Information

Sponsor

University of Alberta

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-05-11.