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

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255159
• Other study ID #: HREBA.CC-21-0353
• Status: Recruiting
• Phase: Phase 2
• Start date: October 15, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Alberta
• Contact: Jonathan Abele
• Phone: 780-407-6907
• Email: jabele[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion-to-lesion comparison of activity on 68Ga-HA-DOTATATE, 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).	Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans
Secondary	SUV of lesions on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans	SUVmax of all lesions on all scans will be recorded and compared to SUVmean of the liver and blood pool	Within 1 year after completion of both 18F-DOPA and 18F-FDG PET/CT scans
Secondary	Assessment of disease progression - 12 months	All available clinical information will be reviewed 12 months after completion of the PET/CT scans with expert determination of treatment response, no treatment response, or disease progression	12 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans
Secondary	Assessment of disease progression - 18 months	All available clinical information will be reviewed at 18 months after completion of the PET/CT scans with expert determination of treatment response, no treatment response, or disease progression	18 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans