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

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888481
• Other study ID #: CC-19-0369
• Status: Recruiting
• Phase: Phase 2
• Start date: February 15, 2022
• Est. completion date: August 31, 2028

Study information

• Verified date: April 2024
• Source: University of Alberta
• Contact: Jonathan Abele, MD
• Phone: 780-407-6907
• Email: jabele[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• 68Ga-HA-DOTATATE
Tracer injection

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - sensitivity	Sensitivity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up	1 year post-scan
Primary	Efficacy - specificity	Specificity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up	1 year post-scan
Secondary	Safety - adverse events - immediate	Assessment of adverse events immediately after tracer injection	Immediately (within 15 minutes) after tracer injection
Secondary	Safety - adverse events - post-scan	Assessment of adverse events immediately after PET/CT scan	Immediately (within 15 minutes) after PET/CT scan; 60 to 100 minutes after tracer injection
Secondary	Safety - adverse events - delayed	Self-reporting of possible adverse events after leaving the PET department	10 days after tracer injection