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Trial registered on ANZCTR


Registration number
ACTRN12617001259336
Ethics application status
Approved
Date submitted
28/08/2017
Date registered
30/08/2017
Date last updated
4/12/2018
Date data sharing statement initially provided
4/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An imaging study of 64Cu-SARTATE using positron emission tomography in paediatric patients with high-risk neuroblastoma.
Scientific title
Positron Emission Tomography (PET) Imaging of Paediatric Patients with High-Risk Neuroblastoma Using 64Cu-SARTATE: A Multi-Centre, Open-Label, Non-Randomised, Phase-1 Imaging Investigation.
Secondary ID [1] 292683 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-Risk Neuroblastoma 304549 0
Condition category
Condition code
Cancer 303871 303871 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
64Cu-SARTATE will be administered at a rate of 2.0MBq/kg (0.054 mCi/kg) of body weight, up to a maximum of 200 MBq (5.4 mCi) given as a single bolus IV injection at day 1. Follow-up will occur at 1 week.
Intervention code [1] 298993 0
Diagnosis / Prognosis
Comparator / control treatment
Subjects will be required to have had a pre-study standard of care whole body 123I- MIBG SPECT scan within 6 weeks, but not closer than 36 hours prior to administration of 64Cu-SARTATE.

Control group
Active

Outcomes
Primary outcome [1] 303226 0
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] 303226 0
At visit 2 (1 day post 64Cu-SARTATE administration) and visit 3 (1 week post 64Cu-SARTATE administration)
Primary outcome [2] 303227 0
Percentage of injected 64Cu-SARTATE dose found in organs of interest at 4hrs and 24hrs post-administration of the investigational product, via whole body PET scan.
Timepoint [2] 303227 0
4hrs and 24hrs post-administration.
Primary outcome [3] 303228 0
Absorbed dose (Sv/MBq) from administered 64Cu-SARTATE in target, non-target organs and whole body as assessed using whole body PET scan (composite outcome).
Timepoint [3] 303228 0
4hrs and 24hrs following administration.
Secondary outcome [1] 338286 0
To determine if the 64Cu-SARTATE PET/CT scans confirm sites of known malignancy determined by other standard of care imaging modalities taken within 6 weeks prior to Day 1.
Timepoint [1] 338286 0
4hrs and 24hrs following administration.
Secondary outcome [2] 338287 0
To determine if treating physician’s opinion of staging or appropriate treatment plan for patients were changed or modified as a result of 64Cu-SARTATE PET/CT scan, based on retrospective post-hoc review of the clinical and imaging data.
Timepoint [2] 338287 0
Retrospectively, at the conclusion of the study.

Eligibility
Key inclusion criteria
1. Signed informed consent by parent or guardian.
2. Age at diagnosis less than or equal to 16 years.
3. Life expectancy greater than or equal to 12 weeks.
4. High-risk neuroblastoma with failure to respond to standard therapy, or development of progressive disease at any time, or patients with unresectable residual primary tumours if unsuitable for external beam radiotherapy.
5. At least one site of disease evaluable by 123I-MIBG SPECT.
6. Adequate recovery from acute toxic effects of any prior therapy.
7. At least one site of somatostatin receptor 2 positive malignancy.
8. Adequate renal function.
9. Karnofsky or Lansky performance status of greater than or equal to 50.
Minimum age
No limit
Maximum age
22 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with disease of any major organ system that would compromise their ability to tolerate therapy, as deemed by the principal investigator or treating sub-investigator.
2. Patients who require sedation during imaging procedures.
3. Patients must not receive chemotherapy, anti-cancer cytokine therapy or
other investigational agents within 2 weeks prior to Day 1.
4. Patients must not be undergoing treatment with long acting somatostatin analogues (administered within 28 days prior to Day 1), or short acting somatostatin analogues (administered within 24hrs prior to Day 1).
5. Patients who are pregnant or lactating are excluded. Patients of childbearing potential must practice an effective method of birth control.
6. Patients who are on hemodialysis.
7. Patients with a QTc interval less than or equal to 0.45 seconds as measured by screening ECG.
8. Patients with uncontrolled infections.
9. Any serious medical condition which the investigator feels may interfere with the
procedures or evaluations of the study.

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)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The 1st primary endpoint, the number of patients who demonstrate an adverse response following 64Cu-SARTATE administration will be reported, and the point estimate and 95% confidence interval (CI) for the true underlying adverse response rate will be estimated using an exact method.
For the 2nd and 3rd primary endpoint, 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 1 trial, evaluating a single dose level, a pragmatic sample size of 10 has been decided upon to enable initial experience with this imaging agent within a reasonable period of time.


Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 8905 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 8908 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 17151 0
2145 - Westmead
Recruitment postcode(s) [2] 17154 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 297325 0
Commercial sector/Industry
Name [1] 297325 0
Clarity Pharmaceuticals LTD
Address [1] 297325 0
Suite 212A National Innovation Centre, ATP
4 Cornwallis St, Eveleigh NSW 2015
Country [1] 297325 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Clarity Pharmaceuticals LTD
Address
Suite 212A National Innovation Centre, ATP
4 Cornwallis St, Eveleigh NSW 2015
Country
Australia
Secondary sponsor category [1] 296379 0
None
Name [1] 296379 0
Address [1] 296379 0
Country [1] 296379 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298427 0
Sydney Children’s Hospitals Network Human Research Ethics Committee (EC00130)
Ethics committee address [1] 298427 0
Corner Hawkesbury Road and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145
Sydney Australia
Ethics committee country [1] 298427 0
Australia
Date submitted for ethics approval [1] 298427 0
27/02/2017
Approval date [1] 298427 0
04/08/2017
Ethics approval number [1] 298427 0
HREC/17/SCHN/64

Summary
Brief summary
The aim of this project is to investigate if a novel tracer called 64Cu­-SARTATE can be used to help accurately image neuroblastoma on PET/CT in pediatric patients.

Who is it for?
Paediatric patients aged 16 years or less diagnosed with high-risk neuroblastoma and life expectancy of 12 weeks or more are eligible for this study.

Study details
Eligible patients will be administered a single dose of 64Cu­-SARTATE and undergo whole body PET scans at 4hrs & 24hrs. Complete safety evaluations will occur during visit 2 (day 2) & the visit 3 (day 8). Three blinded assessors will compare the new scans to the standard of care imaging to determine if they are superior.

We hope that by testing this investigational product in paediatric patients, we can confirm that the biodistribution of 64Cu­-SARTATE will facilitate specific and more sensitive identification of malignant tissues using PET/CT scanning. It is hoped that this method can then be translated into everyday clinical care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77046 0
Prof Robert Howman-Giles
Address 77046 0
The Children's Hospital at Westmead Head, Department of Nuclear Medicine Cnr Hawkesbury Rd and Hainsworth St Westmead, NSW 2145, Australia
Country 77046 0
Australia
Phone 77046 0
+61 2 98452904
Fax 77046 0
Email 77046 0
robert.howmangiles@health.nsw.gov.au
Contact person for public queries
Name 77047 0
Prof Robert Howman-Giles
Address 77047 0
The Children's Hospital at Westmead Head, Department of Nuclear Medicine Cnr Hawkesbury Rd and Hainsworth St Westmead, NSW 2145, Australia
Country 77047 0
Australia
Phone 77047 0
+61 2 98452904
Fax 77047 0
Email 77047 0
robert.howmangiles@health.nsw.gov.au
Contact person for scientific queries
Name 77048 0
Prof Robert Howman-Giles
Address 77048 0
The Children's Hospital at Westmead Head, Department of Nuclear Medicine Cnr Hawkesbury Rd and Hainsworth St Westmead, NSW 2145, Australia
Country 77048 0
Australia
Phone 77048 0
+61 2 98452904
Fax 77048 0
Email 77048 0
robert.howmangiles@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study withdrawn
What supporting documents are/will be available?
No other documents available
Summary results
No Results