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

NCT04888481 | Recruiting Phase 2

• 1 other identifier: CC-19-0369
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (2)

• Efficacy - sensitivity

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

  1 year post-scan

• Efficacy - specificity

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

  1 year post-scan

Secondary Outcomes (3)

• Safety - adverse events - immediate

  Immediately (within 15 minutes) after tracer injection

• Safety - adverse events - post-scan

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

• Safety - adverse events - delayed

  10 days after tracer injection

Study Arms (1)

68Ga-HA-DOTATATE PET/CT scan

EXPERIMENTAL

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

Drug: 68Ga-HA-DOTATATE

Interventions

68Ga-HA-DOTATATE DRUG

Tracer injection

68Ga-HA-DOTATATE PET/CT scan

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

68Ga-DOTA-iodo-Tyr(3)-octreotate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Jonathan Abele, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Abele, MD

CONTACT

780-407-6907; jabele@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: February 15, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)