Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors

NCT05255159 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Alberta

Phase

Phase 2

Started

2022-10-15

Last updated

2025-11-17

Condition(s) studied

Neuroendocrine Tumors

Investigational drug(s) / intervention(s)

18F-DOPA with furosemide

18F-DOPA with furosemide: Diagnostic 18F-DOPA PET/CT scan

Study summary

This study is a single centre non-randomized non-blinded phase II prospective cohort study including 50 participants. The objective of this study is to directly compare 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG activity in patients with metastatic neuroendocrine tumors (NETs) on a lesion-by-lesion basis. The investigators will determine the prevalence of concordant versus discordant disease. Secondary objectives include assessing the standardized uptake value (SUV) and determining if there is any correlation between discordance and disease progression.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Lesion-to-lesion comparison of activity on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans — Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans
Participants will be categorized as having concordant disease (all lesions 68Ga-HA-DOTATATE avid) or discordant disease (one or more lesions not 68Ga-HA-DOTATATE avid).

Trial sites (1)

Facility	City	Region	Status
University of Alberta Hospital	Edmonton	Alberta

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05255159 on ClinicalTrials.gov ↗ ← All trials in Canada