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Trial registered on ANZCTR


Registration number
ACTRN12615000727549
Ethics application status
Approved
Date submitted
20/05/2015
Date registered
15/07/2015
Date last updated
28/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An imaging study of 64Cu-SARTATE using positron emission tomography in patients with neuroendocrine tumours
Scientific title
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
Secondary ID [1] 286762 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low & Intermediate Grade Neuroendocrine Tumors 295135 0
Condition category
Condition code
Cancer 295380 295380 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291918 0
Diagnosis / Prognosis
Comparator / control treatment
Up to 200MBq of 68Ga-DOTA-Octreotate ("68Ga-DOTATATE") given as a single bolus intravenous injection up to 2 weeks prior to the study Day 1. DOTATATE dose will not exceed 20micrograms. DOTATATE is the current gold standard diagnostic method.
Control group
Active

Outcomes
Primary outcome [1] 295115 0
Safety: Occurrence of adverse clinical, biochemical or haematological events following 64Cu-SARTATE administration as assessed using medical history and blood tests (composite outcome) at visit 2 and visit 3.
Timepoint [1] 295115 0
At visit 2 (day 2) and visit 3 (day 8)
Primary outcome [2] 295116 0
Percentage of injected 64Cu-SARTATE dose found in organs of interest at 30mins, 1hr, 4hrs and 24hrs following administration of Investigational Product, via whole body PET scan
Timepoint [2] 295116 0
30mins, 1hr, 4hrs and 24hrs following administration
Primary outcome [3] 295117 0
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)
Timepoint [3] 295117 0
30mins, 1hr, 4hrs and 24hrs following administration
Secondary outcome [1] 314808 0
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.
Timepoint [1] 314808 0
30mins, 1hr, 4hrs and 24hrs following administration
Secondary outcome [2] 314809 0
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.
Timepoint [2] 314809 0
30mins, 1hr, 4hrs and 24hrs following administration

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
"Allocation is not concealed"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For the 1st primary objective, the number of patients who demonstrate an adverse response judged to be related to 64Cu-SARTATE administration, and its 95% CI will be reported.
For the 2nd and 3rd primary objectives, basic descriptive statistics (mean, median and range) will be provided for the % of injected dose and the absorbed dose for each organ of interest, as well as for the whole body dose.
As a Phase 0 trial, up to 10 patients is considered to be sufficient to determine proof of concept.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/05/2015
Actual
21/05/2015
Date of last participant enrolment
Anticipated
30/09/2015
Actual
16/10/2015
Date of last data collection
Anticipated
Actual
25/02/2016
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3813 0
Peter MacCallum Cancer Institute - East Melbourne

Funding & Sponsors
Funding source category [1] 291311 0
Commercial sector/Industry
Name [1] 291311 0
Clarity Pharmaceuticals PTY LTD
Country [1] 291311 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Clarity Pharmaceuticals PTY LTD
Address
Suite 212A National Innovation Centre, ATP
4 Cornwallis St, Eveleigh NSW 2015
Country
Australia
Secondary sponsor category [1] 289991 0
None
Name [1] 289991 0
Address [1] 289991 0
Country [1] 289991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292876 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 292876 0
Ethics committee country [1] 292876 0
Australia
Date submitted for ethics approval [1] 292876 0
Approval date [1] 292876 0
26/02/2015
Ethics approval number [1] 292876 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57438 0
Prof Rodney Hicks
Address 57438 0
Peter MacCallum Cancer Centre
Centre for Cancer Imaging
St Andrews Place
East Melbourne, VIC 3002
Country 57438 0
Australia
Phone 57438 0
+61 3 9656 1111
Fax 57438 0
Email 57438 0
[email protected]
Contact person for public queries
Name 57439 0
Elizabeth Drummond
Address 57439 0
Peter MacCallum Cancer Centre
Centre for Cancer Imaging
St Andrews Place
East Melbourne, VIC 3002
Country 57439 0
Australia
Phone 57439 0
+61 3 9656 1856
Fax 57439 0
Email 57439 0
[email protected]
Contact person for scientific queries
Name 57440 0
Rodney Hicks
Address 57440 0
Peter MacCallum Cancer Centre
Centre for Cancer Imaging
St Andrews Place
East Melbourne, VIC 3002
Country 57440 0
Australia
Phone 57440 0
+61 3 9656 1111
Fax 57440 0
Email 57440 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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