68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors

Sponsor
University of Alberta
Study ID
NCT04888481
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 68Ga-HA-DOTATATE — DRUG
    Tracer injection

Study Details

Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In the past, 111In-octreotide imaging has been used for this purpose but it has been recently supplanted globally by SSR positron emission tomography (PET) imaging due to better image quality and higher diagnostic accuracy. This study will assess the safety and diagnostic effectiveness of 68Ga-HA-DOTATATE produced a the Edmonton Radiopharmaceutical Centre (ERC).

Key Dates

First listed
May 17, 2021
Start date
Feb 15, 2022
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 68Ga-HA-DOTATATE PET/CT scan
    2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging

Primary Outcome Measure

Efficacy - sensitivity [ Time Frame: 1 year post-scan ]

Central Contacts

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