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Trial registered on ANZCTR


Registration number
ACTRN12618001819213
Ethics application status
Approved
Date submitted
30/10/2018
Date registered
8/11/2018
Date last updated
8/11/2018
Date data sharing statement initially provided
8/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A novel PET (positron emission tomography) tracer for donut-like PET findings in patients with neuroendocrine tumours
Scientific title
The role of [18F]FMISO PET in resolving Dotatate uptake in a doNUT-like pattern in neuroendocrine neoplasms
Secondary ID [1] 296472 0
None
Universal Trial Number (UTN)
Trial acronym
DONUT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine tumours 310257 0
Condition category
Condition code
Cancer 308981 308981 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After signing consent, patients will be in the Nuclear Medicine department for approximately 3 hours. The intervention is a one-off injection of [18-F]-FMISO (dosage 300-350MBq), administered by the technologist. Imaging will be a mix of dynamic and static acquisitions from the time of injection to 120 minutes after injection. Standard PET machine settings will otherwise be used.
Intervention code [1] 312797 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307951 0
The % of patients with subjectively assessed FMISO avidity in the target lesion
Timepoint [1] 307951 0
At time of PET imaging
Secondary outcome [1] 353443 0
Distribution of FMISO in target lesion and other tumour lesions - quantitative (SUVmax, peak, mean; ratio of uptake in target versus uptake in normal tissue of same organ) and qualitative assessment (geographical pattern of uptake in lesions). This is a composite outcome.
Timepoint [1] 353443 0
At time of PET scan
Secondary outcome [2] 353444 0
Safety of FMISO injection as assessed by CTCAE v4.03 criteria
Timepoint [2] 353444 0
From the time of the injection to 7 days post injection

Eligibility
Key inclusion criteria
1) Patients 18 years of age or older with metastatic neuroendocrine neoplasm (NEN) and histological confirmation who have undergone PET scans at Royal North Shore Hospital
2) Patients identified by the nuclear medicine physicians as having a lesion with 68Ga-DOTATATE PET (DOTA) avidity on the periphery but not the centre of the lesion (i.e. lack of avidity in the hole of the “donut“-like tumour).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients who have not received a PET scan at RNSH
2) Patients without a histological diagnosis of metastatic NEN
3) Inability to lie in a supine position on the PET scanning bed for 15 minutes;
4) Subjects who required sedation for their baseline clinical PET scan;
5) Renal failure requiring haemo- or peritoneal dialysis;
6) Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the patient’s participation in the study or evaluation of the study results;

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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
Recruitment hospital [1] 12305 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 24501 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 301065 0
Other Collaborative groups
Name [1] 301065 0
Sydney Vital
Address [1] 301065 0
Level 8, Kolling Institute of Medical Research, Reserve Road, St Leonards NSW 2065
Country [1] 301065 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Reserve Road, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 300674 0
None
Name [1] 300674 0
Address [1] 300674 0
Country [1] 300674 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301818 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 301818 0
Kolling Building, Level 13
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 301818 0
Australia
Date submitted for ethics approval [1] 301818 0
21/05/2018
Approval date [1] 301818 0
28/09/2018
Ethics approval number [1] 301818 0
RESP/18/129

Summary
Brief summary
The purpose of this study is to examine the area around a neuroendocrine tumour using a scan called FMISO PET.

Who is it for?
You may be eligible for this study if you are aged 18 or over, and have a metastatic neuroendocrine tumour (NET).

Study details
All participants in this study will undergo one FMISO PET. The scan requires injection of a chemical called a tracer through a needle in the arm. The scan takes approximately 2 hours with the whole study visit on the day taking approximately 3 hours.

It is hoped this research will help clinicians understand the biology of NET better, and help improve health outcomes in the long term as a result of this improved understanding.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88218 0
Dr David Chan
Address 88218 0
Department of Nuclear Medicine
Level 2 ASB
Royal North Shore Hospital
St Leonards NSW 2065
Country 88218 0
Australia
Phone 88218 0
+61 299264440
Fax 88218 0
Email 88218 0
dlhchan1@gmail.com
Contact person for public queries
Name 88219 0
Dr David Chan
Address 88219 0
Department of Nuclear Medicine
Level 2 ASB
Royal North Shore Hospital
St Leonards NSW 2065
Country 88219 0
Australia
Phone 88219 0
+61 299264440
Fax 88219 0
Email 88219 0
dlhchan1@gmail.com
Contact person for scientific queries
Name 88220 0
Dr David Chan
Address 88220 0
Department of Nuclear Medicine
Level 2 ASB
Royal North Shore Hospital
St Leonards NSW 2065
Country 88220 0
Australia
Phone 88220 0
+61 299264440
Fax 88220 0
Email 88220 0
dlhchan1@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Small patient numbers means that sharing IPD may compromise patient anonymity.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable