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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05255159
Other study ID # HREBA.CC-21-0353
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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