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

University of Alberta

Status and phase

Enrolling

Phase 2

Conditions

Neuroendocrine Tumors

Treatments

Drug: 68Ga-HA-DOTATATE

Study type

Interventional

Funder types

Other

Identifiers

NCT04888481

CC-19-0369

Details and patient eligibility

About

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).

Full description

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.

Enrollment

600 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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