Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000655347
Ethics application status
Approved
Date submitted
2/05/2017
Date registered
5/05/2017
Date last updated
5/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Dynamic and static functional imaging and morphological imaging in Neuroendocrine Tumour (NET) with known liver metastases.
Scientific title
Pilot project to assess liver metastases by comparing novel, dynamic and static functional imaging, and also morphological imaging with standard of care in WHO Grade I and Grade II Neuroendocrine Tumour (NET).
Secondary ID [1] 291830 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Tumour (NET) 303075 0
Liver metastases 303095 0
Condition category
Condition code
Cancer 302533 302533 0 0
Liver
Cancer 302554 302554 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will receive a Ga-68-DOTATATE PET/MR and PET/CT Scan at Herston Imaging Research Facility (HIRF) on the same day.

Initial PET-MRI Scan
After emptying your bladder, a qualified Nuclear Medicine Technologist will ask you to lie on the scanner bed. They will insert a tube into your vein and inject a radioactive substance called Ga-68-DOTATATE as well as a special dye called contrast.
The scan involves lying flat with knees supported and arms resting by your side. You will be scanned from the top of your head to the middle of your thighs. The scan time for the PET-MRI will be approximately 45 minutes. During this time the MR part of the scanner will make buzzing or knocking noises as it generates different kinds of images.

PET-CT Scan
You will be asked empty your bladder again and walk to the PET-CT scanner in the room next door. The PET-CT scan involves lying flat and takes approximately 30 minutes to scan you from the top of your head to the middle of your thighs.

Final PET-MRI Scan
After the PET-CT Scan, you will be asked to walk back to the PET-MRI scanner where a final PET-MRI will be performed. This scan will not require any further injections. This scan will go from the top of your head to the middle of your thighs and should take approximately 30 minutes. This scan is performed to directly compare the PET-CT images to the PET-MRI images.
Intervention code [1] 297944 0
Diagnosis / Prognosis
Comparator / control treatment
Comparison of attenuation correction between the MR and CT mu maps will be performed qualitatively via Nuclear Medicine physician and quantitatively via image analysis.

CT attenuation will be considered the gold standard with MR attenuation map compared with it. The comparison will documented as following grading
Grade 1 – no difference
Grade 2 – MR reconstruction suboptimal
Grade 3- MR reconstruction can’t delineate the lesion
Control group
Active

Outcomes
Primary outcome [1] 301953 0
Accuracy of DOTATATE PET/MR imaging compared to the current gold standard of DOTATATE PET/CT in the detection of liver metastases in patients with NETs, graded as follows:
Grade 1 – no difference
Grade 2 – MR reconstruction suboptimal
Grade 3- MR reconstruction can’t delineate the lesion
Timepoint [1] 301953 0
Diagnosis
Secondary outcome [1] 334351 0
Comparison of CT attenuation map to those created by MRI.
Graded by radiologists as follows:
Grade 1 – no difference
Grade 2 – MR reconstruction suboptimal
Grade 3- MR reconstruction can’t delineate the lesion
Timepoint [1] 334351 0
Diagnosis
Secondary outcome [2] 334352 0
Dosimetry over kidneys and liver lesions will be calculated. If a decision is made to proceed to Lutetium-177-DOTATATE radionuclide therapy, current dosimetry will be compared with dosimetry calculated during Lutetium-177-DOTATATE therapy to see if MRI can more accurately assess the renal dose for targeted radionuclide therapy.
Timepoint [2] 334352 0
Diagnosis

Eligibility
Key inclusion criteria
1. Histologically proven WHO Grade I (defined as slowly proliferating tumors, measured on histology by a marker Ki-67 with value of <3%) to WHO Grade II (Ki-67 3-20%) NET with known liver metastases
2. Clinically requires Ga-68-DOTATATE PET-CT scan
3. Liver metastases on diagnostic CT
4. Written informed consent
5. All women of childbearing age must have a pregnancy test before enrolment
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
2. Life expectancy less than 6 months
3. Previously known non-Ga-DOTATATE avid disease.
4. Contraindication to MRI
5. Severe claustrophobia
6. Known renal impairment
7. Hypersensitivity to Primovist

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
Not yet recruiting
Date of first participant enrolment
Anticipated
29/05/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 296328 0
Hospital
Name [1] 296328 0
Royal Birsbane and Women's Hospital, Herston Imaging Research Facility Seed Funding
Country [1] 296328 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Metro North Hospital and Health Service
Royal Brisbane and Women's Hospital
Butterfield Street
Herston Queensland 4029
Country
Australia
Secondary sponsor category [1] 295256 0
None
Name [1] 295256 0
Address [1] 295256 0
Country [1] 295256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297558 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 297558 0
Royal Brisbane and Women's Hospital
Human Research Ethics Committee
Level 7 Block 7
Herston Road Herston Queensland 4029
Ethics committee country [1] 297558 0
Australia
Date submitted for ethics approval [1] 297558 0
27/01/2017
Approval date [1] 297558 0
23/03/2017
Ethics approval number [1] 297558 0
HREC/17/QRBW/52

Summary
Brief summary
The aim of this study is to compare the accuracy of novel, dynamic and static functional imaging, and also morphological imaging, with standard of care imaging for the detection of liver metastases in patients with neuroendocrine tumour (NET).

Who is it for?
You may be eligible to join this study if you aged 18 years or above and have been diagnosed with histologically proven WHO Grade I or Grade II NET with known liver metastases.

Study details
All participants in this study will receive three scans on a single day: an initial PET-MRI Scan, followed by a PET-CT Scan, and then a final PET-MRI Scan. For the initial PET-MRI scan a qualified Nuclear Medicine Technologist will ask you to lie on the scanner bed. They will insert a tube into your vein and inject a radioactive substance called Ga-68-DOTATATE as well as a special dye called contrast. The scan involves lying flat with knees supported and arms resting by your side. You will be scanned from the top of your head to the middle of your thighs. The scan time for the PET-MRI will be approximately 45 minutes. The PET-CT scan involves lying flat and takes approximately 30 minutes to scan you from the top of your head to the middle of your thighs. The final PET-MRI scan will not require any further injections. This scan will go from the top of your head to the middle of your thighs and should take approximately 30 minutes. This scan is performed to directly compare the PET-CT images to the PET-MRI images.

The images generated will be independently reviewed by trained Nuclear Medicine physicians partaking in the study to count the number of liver metastases.
It is hoped that additional dynamic PET may further increase the sensitivity of detecting liver metastases. This may potentially influence treatment options in individual patients, including possibly avoiding futile surgery in patients with more extensive disease burden than detected on current standard imaging
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74434 0
Dr Manoj Bhatt
Address 74434 0
Royal Brisbane and Women's Hospital
Department of Nuclear Medicine
Level 3 Ned Hanlon Building
Herston Road Herston Queensland 4029
Country 74434 0
Australia
Phone 74434 0
+61 7 3646 8111
Fax 74434 0
Email 74434 0
manoj.bhatt@health.qld.gov.au
Contact person for public queries
Name 74435 0
Dr Manoj Bhatt
Address 74435 0
Royal Brisbane and Women's Hospital
Department of Nuclear Medicine
Level 3 Ned Hanlon Building
Herston Road Herston Queensland 4029
Country 74435 0
Australia
Phone 74435 0
+61 7 3646 8111
Fax 74435 0
Email 74435 0
manoj.bhatt@health.qld.gov.au
Contact person for scientific queries
Name 74436 0
Dr Manoj Bhatt
Address 74436 0
Royal Brisbane and Women's Hospital
Department of Nuclear Medicine
Level 3 Ned Hanlon Building
Herston Road Herston Queensland 4029
Country 74436 0
Australia
Phone 74436 0
+61 7 3646 8111
Fax 74436 0
Email 74436 0
manoj.bhatt@health.qld.gov.au

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

Documents added manually
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Documents added automatically
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