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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03145857 on ClinicalTrials.gov