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[68]Ga-HA-DOTATATE Imaging for Neuroendocrine Tumors

Phase 1 & 2
Led By Todd PW McMullen, MD, PhD, FRCSC, FACS
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 14 years of age
Known or suspected somatostatin receptor positive tumour including, but not limited to, GNET, PNET, pulmonary NET, PRUNK NET, pheochromocytoma, paraganglioma, medullary thyroid cancer, and medulloblastoma
Must not have
Allergic reaction to DOTATATE or somatostatin analogues
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights


This trial will compare the [68]Ga-HA-DOTATATE PET/CT or PET/MRI scan to an Octreoscan™ in patients with known or suspected NETs.

Who is the study for?
This trial is for individuals at least 14 years old with suspected or known tumors that have somatostatin receptors, such as various types of neuroendocrine tumors. Participants must be able to follow the study's protocol and have an ECOG score ≤ 3, indicating they are capable of self-care. They cannot join if they exceed the weight limit for PET scans, are pregnant, allergic to DOTATATE/somatostatin analogues, or unable to remain still during imaging.Check my eligibility
What is being tested?
[68]Ga-HA-DOTATATE is being tested in this trial. It's a new diagnostic agent used in PET/CT or PET/MRI scans to detect somatostatin receptors on tumors more accurately than current methods like Octreoscan™. The study aims to ensure it's safe and effective for identifying these types of tumors.See study design
What are the potential side effects?
While the main focus is on safety and effectiveness rather than side effects, potential risks may include reactions similar to those from other contrast agents used in imaging studies: mild pain or discomfort at injection site, nausea, itching or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am 14 years old or older.
My tumor is suspected to be positive for somatostatin receptors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I am allergic to DOTATATE or similar drugs.
I cannot stay still for long periods due to a condition like severe arthritis.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in vital signs after first [68]Ga-HA-DOTATATE injection (safety sub-group)
Changes in haematology and biochemistry after first [68]Ga-HA-DOTATATE injection (safety sub-group)
Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care CT or MRI
+2 more
Secondary outcome measures
Evaluation of [68]Ga-HA-DOTATATE scan changes compared to baseline scan

Trial Design

1Treatment groups
Experimental Treatment
Group I: [68]Ga-HA-DOTATATEExperimental Treatment1 Intervention
All participants will be imaged with [68]Ga-HA-DOTATATE PET/CT or PET/MRI for uptake by somatostatin receptor positive tumours. Up to seven [68]Ga-HA-DOTATATE scans may be performed per participant, as clinically indicated.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Neuroendocrine Tumors (NETs) often target somatostatin receptors, similar to the [68]Ga-HA-DOTATATE used for tumor visualization. Somatostatin analogs, such as octreotide and lanreotide, bind to these receptors to inhibit hormone secretion and slow tumor growth. Peptide receptor radionuclide therapy (PRRT), like Lutetium Lu-177 dotatate, uses radiolabeled somatostatin analogs to deliver targeted radiation to NET cells, leading to cell death. These targeted treatments are essential for NET patients as they offer effective control of tumor growth and symptom management.
In- and Y-DOTA-lanreotide: results and implications of the MAURITIUS trial.

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
26,331 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
207 Patients Enrolled for Neuroendocrine Tumors
Todd PW McMullen, MD, PhD, FRCSC, FACSPrincipal InvestigatorAssociate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology

Media Library

[68]Ga-HA-DOTATATE Clinical Trial Eligibility Overview. Trial Name: NCT03145857 — Phase 1 & 2
Neuroendocrine Tumors Research Study Groups: [68]Ga-HA-DOTATATE
Neuroendocrine Tumors Clinical Trial 2023: [68]Ga-HA-DOTATATE Highlights & Side Effects. Trial Name: NCT03145857 — Phase 1 & 2
[68]Ga-HA-DOTATATE 2023 Treatment Timeline for Medical Study. Trial Name: NCT03145857 — Phase 1 & 2
~314 spots leftby Dec 2031