Imaging of suspected somatostatin receptor positive tumors using 68Ga-HA-DOTATATE

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and diagnostic effectiveness of 68Ga-HA-DOTATATE PET/CT imaging in patients with known or suspected somatostatin receptor positive tumors. It is a single center, non-randomized, non-blinded phase II prospective cohort study conducted at the University of Alberta Hospital. Up to 600 scans will be performed over a period of 6 years, including patients of all ages. The study will compare the efficacy of this imaging technique against standard CT and MRI based on a one-year follow-up clinical evaluation.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Jonathan Abele, MD — University of Alberta
• Study coordinator: Jonathan Abele, MD
• Email: jabele@ualberta.ca
• Phone: 780-407-6907

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.