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

June 18, 2020 updated by: Clarity Pharmaceuticals Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection.
Drug: 64Cu-SARTATE
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 week post administration
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
At 30 minutes following administration
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
At 1 hour following administration
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
At 4 hours following administration
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
At 24 hours following administration
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)
At 30 minutes following administration
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)
At 1 hour following administration
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)
At 4 hours following administration
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)
At 24 hours following administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
30 minutes, 1 hour, 4 hours and 24 hours following administration
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.
30 minutes, 1 hour, 4 hours and 24 hours following administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clarity Pharmaceuticals Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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