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

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT05255159•University of Alberta

View on ClinicalTrials.gov

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

Age

40 - No limit years

Sex

ALL

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

Locations (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Key Dates

Start Date

October 15, 2022

Primary Completion Date

June 30, 2025

Completion Date

June 30, 2026

Last Updated

November 17, 2025

Enrollment

ACTUAL participants

Conditions

Neuroendocrine Tumors

Interventions

18F-DOPA with furosemide

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RECRUITINGPHASE2

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Neuroendocrine TumorsWell-Differentiated Neuroendocrine Carcinoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Lurbinectedin With or Without Avelumab in Small Cell Carcinoma of the Bladder (LASER)

Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors

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