drugset / Trial / 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

NCT03145857 ↗

Phase 1/2 Recruiting 1534 enrolled AHS Cancer Control Alberta
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2020-03-05
Primary completion
2040-08
Completion
2046-08

Drugs

EvaluationDrugModalityDoseRoute
Subject 68Ga-HA-DOTATATE Diagnostic / imaging agent — —