68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors

Last updated: May 5, 2025
Sponsor: University of Alberta
Overall Status: Active - Recruiting

Phase

2

Condition

Abdominal Cancer

Carcinoid Syndrome And Carcinoid Tumours

Digestive System Neoplasms

Treatment

68Ga-HA-DOTATATE

Clinical Study ID

NCT04888481
CC-19-0369
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with known or clinically suspected somatostatin receptor positive tumorsincluding but not limited to: gastrointestinal neuroendocrine tumors, pancreaticneuroendocrine 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

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 otherextenuating circumstance that, in the opinion of the investigator or attendingdepartment physician, may significantly interfere with study performance orinterpretation

  • Previous allergic reaction to DOTATATE or somatostatin analogues

  • Lack of intravenous access

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: 68Ga-HA-DOTATATE
Phase: 2
Study Start date:
February 15, 2022
Estimated Completion Date:
August 31, 2028

Study Description

A single centre non-randomized, non-blinded phase II prospective cohort study evaluating the safety and efficacy of 68Ga-HA-DOTATATE PET/CT imaging in patients with known or suspected somatostatin receptor positive tumors.

Up to 600 scans will be included over 6 years. All patient ages (pediatric and adult) will be included. Individual patients may have more than one scan during the study period.

Safety evaluation will consist of an adverse event assessment whil in the Nuclear Medicine department at the University of Alberta Hospital. Efficacy evaluation will consist of a comparison to CT and/or MRI accuracy based on 1 year follow-up clinical evaluation.

Connect with a study center

  • University of Alberta

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.