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

Phase 2RecruitingNCT04888481

University of Alberta600 enrolled

Overview

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).

A single centre non-randomized, non-blinded phase II prospective cohort study evaluating the safety and efficacy of 68Ga-HA-DOTATATE PET/CT imaging in patients with known or suspected somatostatin receptor positive tumors. Up to 600 scans will be included over 6 years. All patient ages (pediatric and adult) will be included. Individual patients may have more than one scan during the study period. Safety evaluation will consist of an adverse event assessment whil in the Nuclear Medicine department at the University of Alberta Hospital. Efficacy evaluation will consist of a comparison to CT and/or MRI accuracy based on 1 year follow-up clinical evaluation.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

600

Conditions

Neuroendocrine Tumors

Interventions

68Ga-HA-DOTATATEDRUG

Tracer injection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma * A standard clinical CT or MRI is obtained within 6 months of enrollment * Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker) Exclusion Criteria: * Weight \> 225 kg (weight limit of the PET/CT scanner) * Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging * Any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation * Previous allergic reaction to DOTATATE or somatostatin analogues * Lack of intravenous access

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

RECRUITING

Outcomes

Primary Outcomes

Efficacy - sensitivity

Sensitivity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up

Time frame: 1 year post-scan

Efficacy - specificity

Specificity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up

Time frame: 1 year post-scan

Secondary Outcomes

Safety - adverse events - immediate

Assessment of adverse events immediately after tracer injection

Time frame: Immediately (within 15 minutes) after tracer injection

Safety - adverse events - post-scan

Assessment of adverse events immediately after PET/CT scan

Time frame: Immediately (within 15 minutes) after PET/CT scan; 60 to 100 minutes after tracer injection

Safety - adverse events - delayed

Self-reporting of possible adverse events after leaving the PET department

Time frame: 10 days after tracer injection

Central Contacts

Jonathan Abele, MD

CONTACT

780-407-6907 jabele@ualberta.ca

Data from ClinicalTrials.gov

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