Comparing PET/CT scans for metastatic neuroendocrine tumors
Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors
This study is testing three different types of PET/CT scans to see which one works best for spotting metastatic neuroendocrine tumors in patients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05255159 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of three different PET/CT imaging agents—68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG—in patients with metastatic neuroendocrine tumors (NETs). It involves a single center, non-randomized, non-blinded phase II prospective cohort design with 50 participants. The primary goal is to compare the imaging results on a lesion-by-lesion basis to identify concordant and discordant disease activity. Secondary objectives include measuring standardized uptake values (SUV) and exploring correlations between discordance and disease progression.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40 and older with biopsy-proven metastatic neuroendocrine tumors and at least two abnormal lesions detected by 68Ga-HA-DOTATATE.
Not a fit: Patients who weigh over 225 kg or have conditions that prevent them from undergoing PET/CT scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of imaging techniques for diagnosing and monitoring metastatic neuroendocrine tumors.
How similar studies have performed: While there have been studies on imaging for neuroendocrine tumors, this specific comparison of these three agents on a lesion-by-lesion basis is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of biopsy proven neuroendocrine tumor including (but not limited to): gastrointestinal NET, pancreatic NET, pulmonary NET, NET unknown primary, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma * At least two abnormal 68Ga-HA-DOTATATE positive lesions suspected to represent neuroendocrine tumor (at least tow lesions with SUVmax \> SUV meanliver). * Age greater or equal to 40 * Ability to provide written informed consent prior to participation in the study Exclusion Criteria: * Weight \> 225 kg (weight limitation of PET/CT scanner) * Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging * Any 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 18F-DOPA * Lack of intravenous access * Pregnant * Breastfeeding * Less than 40 years old
Where this trial is running
Edmonton, Alberta
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Jonathan Abele — University of Alberta
- Study coordinator: Jonathan Abele
- 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.