Clinical trial NCT04888481: 68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Official title: 68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Neuroendocrine Tumors
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy - sensitivity
timeFrame: 1 year post-scan
measure: Efficacy - specificity
timeFrame: 1 year post-scan
Secondary outcomes:
measure: Safety - adverse events - immediate
timeFrame: Immediately (within 15 minutes) after tracer injection
measure: Safety - adverse events - post-scan
timeFrame: Immediately (within 15 minutes) after PET/CT scan; 60 to 100 minutes after tracer injection
measure: Safety - adverse events - delayed
timeFrame: 10 days after tracer injection
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jonathan Abele, MD
role: PRINCIPAL_INVESTIGATOR
References: