Actively Recruiting

Phase 1
Phase 2
Age: 14Years +
All Genders
NCT03145857

A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use

Led by AHS Cancer Control Alberta · Updated on 2025-05-14

1534

Participants Needed

1

Research Sites

1377 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A \[68\]Ga-HA-DOTATATE PET/CT or PET/MRI scan is a nuclear medicine test used to create pictures of the whole body that will show where somatostatin receptors are found, including on tumours. Somatostatin receptors are found on most neuroendocrine tumours (NETs), and some other types of tumours. Currently at the Cross Cancer Institute, most patients with suspected somatostatin positive tumours (e.g. NETs) have an In-111 Octreotide (Octreoscan™) scan. A scientific study has shown that a scan with a similar product (\[68\]Ga-DOTATATE) is more accurate than an Octreoscan™. This study will look at \[68\]Ga-HA-DOTATATE, a product virtually identical to \[68\]Ga-DOTATATE. The purpose of this study is to: 1) demonstrate the safety of \[68\]Ga-HA-DOTATATE; and 2) confirm that \[68\]Ga-HA-DOTATATE PET/CT or PET/MRI is effective at diagnosing somatostatin positive tumours.

CONDITIONS

Official Title

A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Known or suspected somatostatin receptor positive tumor including types such as GNET, PNET, pulmonary NET, pheochromocytoma, paraganglioma, medullary thyroid cancer, and medulloblastoma
  • Standard CT scan obtained within 6 months before enrollment
  • Eastern Cooperative Oncology Group (ECOG) Performance Scale Score of 3 or less within 2 weeks before enrollment
  • At least 14 years of age
  • Able and willing to follow instructions and comply with the protocol
  • Able to provide written informed consent before participating in the study
Not Eligible

You will not qualify if you...

  • Unable to lie still for the entire imaging time (e.g., due to cough or severe arthritis)
  • Unable to complete required imaging exams due to claustrophobia, radiation phobia, or other reasons
  • Any serious medical condition or illness that may interfere with study participation or results
  • Weight exceeding the PET/CT or PET/MR scanner limit
  • Pregnant
  • Allergic reaction to DOTATATE or somatostatin analogues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

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Research Team

N

NET Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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