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Active, Not Recruiting

NCT Number: NCT05255159

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-DOPA with furosemide

Diagnostic Test

Diagnostic 18F-DOPA PET/CT scan

Primary outcomes

  1. Lesion-to-lesion comparison of activity on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans

    Time frame: Within 1 year after completion of both 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).

Secondary outcomes

  1. SUV of lesions on 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT scans

    Time frame: Within 1 year after completion of both 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

  2. Assessment of disease progression - 12 months

    Time frame: 12 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans

    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

  3. Assessment of disease progression - 18 months

    Time frame: 18 months after completion of the 68Ga-HA-DOTATATE, 18F-FDG, and investigational 18F-DOPA PET/CT scans

    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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2022
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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