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68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04888481
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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Brief Summary:

Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In the past, 111In-octreotide imaging has been used for this purpose but it has been recently supplanted globally by SSR positron emission tomography (PET) imaging due to better image quality and higher diagnostic accuracy.

This study will assess the safety and diagnostic effectiveness of 68Ga-HA-DOTATATE produced a the Edmonton Radiopharmaceutical Centre (ERC).


Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: 68Ga-HA-DOTATATE Phase 2

Detailed Description:

A single centre non-randomized, non-blinded phase II prospective cohort study evaluating the safety and efficacy of 68Ga-HA-DOTATATE PET/CT imaging in patients with known or suspected somatostatin receptor positive tumors.

Up to 600 scans will be included over 6 years. All patient ages (pediatric and adult) will be included. Individual patients may have more than one scan during the study period.

Safety evaluation will consist of an adverse event assessment whil in the Nuclear Medicine department at the University of Alberta Hospital. Efficacy evaluation will consist of a comparison to CT and/or MRI accuracy based on 1 year follow-up clinical evaluation.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Actual Study Start Date : February 15, 2022
Estimated Primary Completion Date : August 31, 2027
Estimated Study Completion Date : August 31, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 68Ga-HA-DOTATATE PET/CT scan
2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging
 Drug: 68Ga-HA-DOTATATE
Tracer injection


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy - sensitivity [ Time Frame: 1 year post-scan ]
    Sensitivity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up

  2. Efficacy - specificity [ Time Frame: 1 year post-scan ]
    Specificity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up


Secondary Outcome Measures :
  1. Safety - adverse events - immediate [ Time Frame: Immediately (within 15 minutes) after tracer injection ]
    Assessment of adverse events immediately after tracer injection

  2. Safety - adverse events - post-scan [ Time Frame: Immediately (within 15 minutes) after PET/CT scan; 60 to 100 minutes after tracer injection ]
    Assessment of adverse events immediately after PET/CT scan

  3. Safety - adverse events - delayed [ Time Frame: 10 days after tracer injection ]
    Self-reporting of possible adverse events after leaving the PET department


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma
  • A standard clinical CT or MRI is obtained within 6 months of enrollment
  • Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker)

Exclusion Criteria:

  • Weight > 225 kg (weight limit of the PET/CT scanner)
  • Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
  • Any additional 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 DOTATATE or somatostatin analogues
  • Lack of intravenous access
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): NCT04888481


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

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Jonathan Abele, MD         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Jonathan Abele, MD University of Alberta
More Information
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04888481    
Other Study ID Numbers: CC-19-0369
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023
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