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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

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ClinicalTrials.gov Identifier: NCT05255159
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : November 21, 2022
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Diagnostic Test: 18F-DOPA with furosemide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors
Actual Study Start Date : October 15, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 18F-DOPA PET/CT scan
4 MBq/kg (minimum 100 MBq, maximum 600 MBq) 18F-DOPA injected intravenously with 40 mg furosemide and subsequent whole body PET/CT scan
 Diagnostic Test: 18F-DOPA with furosemide
Diagnostic 18F-DOPA PET/CT scan


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05255159


Contacts
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Contact: Jonathan Abele 780-407-6907 jabele@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Jonathan Abele    780-407-6907    jabele@ualberta.ca   
Principal Investigator: Jonathan Abele         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Jonathan Abele University of Alberta
More Information
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT05255159    
Other Study ID Numbers: HREBA.CC-21-0353
First Posted: February 24, 2022    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Furosemide
 Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action