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

University of Alberta

Status and phase: Active, not recruiting; Phase 2

Conditions: Neuroendocrine Tumors

Treatments: Diagnostic Test: 18F-DOPA with furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT05255159

HREBA.CC-21-0353

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

18F-DOPA PET/CT scan

Experimental group

Description:

4 MBq/kg (minimum 100 MBq, maximum 600 MBq) 18F-DOPA injected intravenously with 40 mg furosemide and subsequent whole body PET/CT scan

Treatment:

Diagnostic Test: 18F-DOPA with furosemide