An imaging study of 64Cu-SARTATE using positron emission tomography in patients with neuroendocrine tumours

Safety and Potential Effectiveness of 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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000727549

Enrollment

Registered

2015-07-15

Start date

2015-05-21

Completion date

2015-10-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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. Who is it for? You may be eligible to join this study if you are aged 18 years or over, have a life expectancy of 8 weeks or more and Low and Intermediate Grade (Ki-67 index <20%) neuroendocrine tumors (NET). Study details: All participants in this study will be injected with a single dose of 64Cu-SARTATE (a drug molecule). The study lasts for one week and the patient is administered 1 dose of the drug followed by whole body PET scans at 30mins, 1hr, 4hrs, & 24hrs. Complete safety evaluations will occur during visit 2 (day 2) & visit 3 (day 8). These scans will be compared to the current PET imaging standard called 68Ga-DOTATATE which you will have recently received as a standard procedure. It is hoped that this research will help to develop a product which is more accurate for the diagnosis of neuroendocrine tumours in patients.

Interventions

200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection at day 1. SARTATE dose will not exceed 10micrograms. Followup will occur at 1 week.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

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

Outcome results