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An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours

Primary Purpose

Neuroendocrine Tumors

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
64Cu-SARTATE
Sponsored by
Clarity Pharmaceuticals Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent
  2. Age greater than or equal to 18 years
  3. Life expectancy greater than or equal to 8 weeks
  4. Low and Intermediate Grade (Ki-67 index <20%) neuroendocrine tumors (NET)
  5. At least one site of active somatostatin receptor positive malignancy, as demonstrated on the pre-study 68Ga-DOTATATE PET/CT scan performed as part of routine clinical care
  6. Subjects with an estimated glomerular filtration rate (eGFR) greater than 60ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease).
  7. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2

Exclusion Criteria:

  1. Pregnant or breastfeeding females
  2. Known sensitivity or allergy to somatostatin analogues
  3. Subjects who have received interventional treatment for their NET in the interval between 68Ga-DOTATATE PET/CT & 64Cu-SARTATE PET/CT scan
  4. Treatment with long acting somatostatin analogues within 28 days prior to the administration of Investigational Product
  5. Treatment with short acting somatostatin analogues within 24hrs prior to the administration of Investigational Product
  6. QTc interval greater than 0.44seconds as measured by screening ECG
  7. Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
  8. Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection.

    Outcomes

    Primary Outcome Measures

    Incidence of adverse events related to 64Cu-SARTATE
    Occurrence of adverse clinical, biochemical or haematological events assessed for up to 1 week post administration of 64Cu-SARTATE.
    Percentage of injected 64Cu-SARTATE dose found in organs of interest
    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
    Percentage of injected 64Cu-SARTATE dose found in organs of interest
    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
    Percentage of injected 64Cu-SARTATE dose found in organs of interest
    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
    Percentage of injected 64Cu-SARTATE dose found in organs of interest
    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
    Absorbed organ dose
    Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
    Absorbed organ dose
    Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
    Absorbed organ dose
    Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
    Absorbed organ dose
    Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)

    Secondary Outcome Measures

    Demonstration of known malignancy
    Whether 64Cu-SARTATE PET/CT scans demonstrate known sites of 68Ga-DOTATATE avid malignancy with equivalent or greater tumor to background ratios, where background uptake is that found in a non-tumor containing area of interest as decided upon by the nuclear medicine physician at the time of scan assessment.
    Uptake in non-physiological, non-tumor containing tissues
    Whether 64Cu-SARTATE PET/CT scans demonstrate any non-physiological, non-tumor containing tissues with uptake greater than 1.5 x that of the background, where background uptake is defined as in secondary endpoint.

    Full Information

    First Posted
    June 11, 2020
    Last Updated
    June 18, 2020
    Sponsor
    Clarity Pharmaceuticals Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04440956
    Brief Title
    An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours
    Official Title
    Positron Emission Tomography (PET) Imaging of Patients With Low & Intermediate Grade Neuroendocrine Tumors Using 64Cu-SARTATE: A Single Centre, Open-Label, Non-Randomized, Phase-0 Microdosing Investigation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 21, 2015 (Actual)
    Primary Completion Date
    February 25, 2016 (Actual)
    Study Completion Date
    February 25, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Clarity Pharmaceuticals Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The primary purpose of this study is to examine the safety and potential effectiveness of a drug molecule called 64Cu-SARTATE as a potential new way to detect neuroendocrine cancers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuroendocrine Tumors

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection.
    Intervention Type
    Drug
    Intervention Name(s)
    64Cu-SARTATE
    Other Intervention Name(s)
    64Cu-MeCOSar-Octreotate
    Intervention Description
    200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.
    Primary Outcome Measure Information:
    Title
    Incidence of adverse events related to 64Cu-SARTATE
    Description
    Occurrence of adverse clinical, biochemical or haematological events assessed for up to 1 week post administration of 64Cu-SARTATE.
    Time Frame
    1 week post administration
    Title
    Percentage of injected 64Cu-SARTATE dose found in organs of interest
    Description
    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
    Time Frame
    At 30 minutes following administration
    Title
    Percentage of injected 64Cu-SARTATE dose found in organs of interest
    Description
    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
    Time Frame
    At 1 hour following administration
    Title
    Percentage of injected 64Cu-SARTATE dose found in organs of interest
    Description
    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
    Time Frame
    At 4 hours following administration
    Title
    Percentage of injected 64Cu-SARTATE dose found in organs of interest
    Description
    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan
    Time Frame
    At 24 hours following administration
    Title
    Absorbed organ dose
    Description
    Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
    Time Frame
    At 30 minutes following administration
    Title
    Absorbed organ dose
    Description
    Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
    Time Frame
    At 1 hour following administration
    Title
    Absorbed organ dose
    Description
    Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
    Time Frame
    At 4 hours following administration
    Title
    Absorbed organ dose
    Description
    Absorbed organ doses expressed as micro Sv/MBq of administered 64Cu-SARTATE, and whole body dose expressed as milliSv/200MBq of administered dose as assessed using whole body PET scan (composite outcome)
    Time Frame
    At 24 hours following administration
    Secondary Outcome Measure Information:
    Title
    Demonstration of known malignancy
    Description
    Whether 64Cu-SARTATE PET/CT scans demonstrate known sites of 68Ga-DOTATATE avid malignancy with equivalent or greater tumor to background ratios, where background uptake is that found in a non-tumor containing area of interest as decided upon by the nuclear medicine physician at the time of scan assessment.
    Time Frame
    30 minutes, 1 hour, 4 hours and 24 hours following administration
    Title
    Uptake in non-physiological, non-tumor containing tissues
    Description
    Whether 64Cu-SARTATE PET/CT scans demonstrate any non-physiological, non-tumor containing tissues with uptake greater than 1.5 x that of the background, where background uptake is defined as in secondary endpoint.
    Time Frame
    30 minutes, 1 hour, 4 hours and 24 hours following administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent Age greater than or equal to 18 years Life expectancy greater than or equal to 8 weeks Low and Intermediate Grade (Ki-67 index <20%) neuroendocrine tumors (NET) At least one site of active somatostatin receptor positive malignancy, as demonstrated on the pre-study 68Ga-DOTATATE PET/CT scan performed as part of routine clinical care Subjects with an estimated glomerular filtration rate (eGFR) greater than 60ml/min as measured using the MDRD formula (Modification of Diet in Renal Disease). Eastern Cooperative Oncology Group (ECOG) performance score of 0-2 Exclusion Criteria: Pregnant or breastfeeding females Known sensitivity or allergy to somatostatin analogues Subjects who have received interventional treatment for their NET in the interval between 68Ga-DOTATATE PET/CT & 64Cu-SARTATE PET/CT scan Treatment with long acting somatostatin analogues within 28 days prior to the administration of Investigational Product Treatment with short acting somatostatin analogues within 24hrs prior to the administration of Investigational Product QTc interval greater than 0.44seconds as measured by screening ECG Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours

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