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Completed

NCT Number: NCT04440956

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

64Cu-SARTATE

Drug

200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms.

Other names: 64Cu-MeCOSar-Octreotate

Primary outcomes

  1. Incidence of adverse events related to 64Cu-SARTATE

    Time frame: 1 week post administration

    Occurrence of adverse clinical, biochemical or haematological events assessed for up to 1 week post administration of 64Cu-SARTATE.

  2. Percentage of injected 64Cu-SARTATE dose found in organs of interest

    Time frame: At 30 minutes following administration

    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan

  3. Percentage of injected 64Cu-SARTATE dose found in organs of interest

    Time frame: At 1 hour following administration

    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan

  4. Percentage of injected 64Cu-SARTATE dose found in organs of interest

    Time frame: At 4 hours following administration

    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan

  5. Percentage of injected 64Cu-SARTATE dose found in organs of interest

    Time frame: At 24 hours following administration

    Percentage of injected 64Cu-SARTATE dose found in organs of interest via whole body PET scan

  6. Absorbed organ dose

    Time frame: At 30 minutes following administration

    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)

  7. Absorbed organ dose

    Time frame: At 1 hour following administration

    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)

  8. Absorbed organ dose

    Time frame: At 4 hours following administration

    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)

  9. Absorbed organ dose

    Time frame: At 24 hours following administration

    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 outcomes

  1. Demonstration of known malignancy

    Time frame: 30 minutes, 1 hour, 4 hours and 24 hours following administration

    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.

  2. Uptake in non-physiological, non-tumor containing tissues

    Time frame: 30 minutes, 1 hour, 4 hours and 24 hours following administration

    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.

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Clarity Pharmaceuticals Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

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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