Clinical Trial · NCT05255159

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

Overview

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.

Sponsor

University of Alberta

Phase

Phase 2

Contacts

Jonathan Abele (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05255159

Drug / Compound

DOPA

Isotope(s):

Target(s):

Amino Acid Transport

Ligand Class: Small Molecules

HA-DOTATATE

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

At least two abnormal 68Ga-HA-DOTATATE positive lesions suspected to represent neuroendocrine tumor (at least tow lesions with SUVmax \> SUV meanliver).
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

Exclusion

Breastfeeding
Lack of intravenous access
Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
Weight \> 225 kg (weight limitation of PET/CT scanner)
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
Pregnant