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
NCT03145857 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1534
Last updated 2025-05-14
Summary
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
Interventions
- DRUG
-
[68]Ga-HA-DOTATATE
All participants will be injected with \[68\]Ga-HA-DOTATATE approximately 60 minutes before PET/CT or PET/MRI scan.
Sponsors & Collaborators
-
AHS Cancer Control Alberta
lead OTHER
Principal Investigators
-
Todd PW McMullen, MD, PhD, FRCSC, FACS · Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-05
- Primary Completion
- 2040-08-31
- Completion
- 2046-08-31
Countries
- Canada
Study Locations
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