Imaging of suspected somatostatin receptor positive tumors using 68Ga-HA-DOTATATE
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
This study is testing a new type of imaging called 68Ga-HA-DOTATATE PET/CT to see if it can better help people with suspected somatostatin receptor positive tumors compared to regular CT and MRI scans.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04888481 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with known or suspected somatostatin receptor positive tumors such as gastrointestinal, pancreatic, or pulmonary neuroendocrine tumors.
Not a fit: Patients who weigh over 225 kg or have conditions that prevent them from undergoing imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could provide more accurate diagnoses for patients with neuroendocrine tumors, leading to better treatment decisions.
How similar studies have performed: Previous studies have shown that SSR PET imaging techniques can provide improved diagnostic accuracy compared to traditional imaging methods, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.