Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001809224
Ethics application status
Approved
Date submitted
9/07/2018
Date registered
6/11/2018
Date last updated
6/11/2018
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can MRI accurately assess metastasis in the abdominal cavity from ovarian cancer?
Scientific title
Can diffusion-weighted MRI replace exploratory laparoscopy in the assessment of peritoneal carcinomatosis from ovarian cancer?
Secondary ID [1] 295419 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DW-MRI-OC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 308655 0
Condition category
Condition code
Cancer 307595 307595 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All study patients will have a diffusion weighted MRI scan prior to surgery.
This is a single MRI which will take approximately 1 hour to perform. It will be performed up to a week prior to surgery.

Three T high field strength MR scanner will be used . High performance gradients (50 mT/m, 200 mT/m/sec) are advantageous for high quality DW imaging.

The MRI scan will be performed by the MRI radiographer with the radiologist supervising.

Intravenous gadolinium contrast will be administered using a power injector at an injection rate of 2 cc per second. We will use a single dose 0.1 mmol/kg of MultiHance® (gadobenate dimeglumine) (Bracco).
Intervention code [1] 301725 0
Diagnosis / Prognosis
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306573 0
assess the extent of cancer assessed by Peritoneal Cancer Index (PCI) using MRI
Timepoint [1] 306573 0
Surgically score PCI will occur in theatre and Radiologically scored PCI will occur up to a week before surgery.
Primary outcome [2] 307973 0
assess the extent of cancer seen at surgery assessed Peritoneal Cancer Index (PCI) determined by surgeon
Timepoint [2] 307973 0
Surgically score PCI will occur in theatre
Secondary outcome [1] 348917 0
Comorbidities as assessed by data-linkage to medical records. These include the presence or absence of cardiac disease, respiratory disease, a history of heart attack or stroke, the presence of diabetes,

Timepoint [1] 348917 0
This data will be recorded at the clinical consultation prior to both the MRI and the surgery. It is standard clinical data collection in this condition

Eligibility
Key inclusion criteria
1. diagnosis of metastatic ovarian cancer and who can
2. ability to give informed consent
3. happy to participate
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who have a heart pacemaker may not have an MRI scan
• Patients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
• Patients with severe claustrophobia may not be able to tolerate an MRI scan, although more open scanners are now available, and medical sedation is available to make the test easier to tolerate
• Patients who have had metallic devices placed in their back (such as pedicle screws or anterior interbody cages) can have an MRI scan, but the resolution of the scan is often severely hampered by the metal device and the spine is not well imaged.

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)
No Applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We used the sample size recommended by Bland(2004) based on the Bland Altman method (Bland +Altman 1986) This guideline is not based on a formal powering process as the Bland-Altman approach is not inferential. Bland 2004 recommends a sample of at least 100 patients for the Bland –Altman approach.

We employed both the ICC (Intra class correlation) and the Bland Altman approach to guage both inter-method and inter-rater (within MRI) agreement. The ICC was used as it provides a single measure of agreement with a 95% CI. Where as Bland Altman was used because it is much more informative about the specific causes of lack of agreement (bias, Noise, Spectrum Bias, Spectrum noise) Bland Altman is also much more intuitive.

We will compare the radiologically scored PCI with the surgically scored PCI using paired t-testing

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/12/2018
Actual
Date of last participant enrolment
Anticipated
1/08/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 23205 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 300005 0
Charities/Societies/Foundations
Name [1] 300005 0
Mater Foundation
Country [1] 300005 0
Australia
Primary sponsor type
Hospital
Name
Mater Adults Hospital
Address
Raymond Terrace, South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 299390 0
None
Name [1] 299390 0
Address [1] 299390 0
Country [1] 299390 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300859 0
Mater Misericordiae Ltd Human Research Ethics Committee [EC00332].
Ethics committee address [1] 300859 0
Mater Adults Hospital
Raymond Terrace
South Brisbane
Qld
4101
Ethics committee country [1] 300859 0
Australia
Date submitted for ethics approval [1] 300859 0
14/05/2018
Approval date [1] 300859 0
23/07/2018
Ethics approval number [1] 300859 0
EC00332

Summary
Brief summary
This research study is designed to assess whether a special MRI scan can accurately predict the extent of cancer spread in the abdominal cavity in advanced ovarian cancer.

Who is it for?
You may be eligible for this study if you have a diagnosis of metastatic ovarian cancer and are aged over 18 years old.

Study details
All participants in this study will undergo an MRI scan no longer than 2 weeks prior to their routine diagnostic laparoscopy. This scan will take approximately 60 minutes. Participants will also give informed consent for access to their medical records.

It is hoped this research might demonstrate that MRI scans can replace surgery when assessing the spread of advanced ovarian cancer in the abdominal cavity.
Trial website
Trial related presentations / publications
Public notes
The aim of the study is to compare the radiologically scored PCI with our surgically scored PCI. We will determine if MRI can replace laparoscopy in the work up for ovarian cancer definitive surgery. The primary objective is to assess if MRI scored PCI equates to surgically scored PCI. The secondary objectives are to identify if personal factors affect the sensitivity of the test (ethnicity, body habitus, age, diabetes, smoking status, neoadjuvant chemotherapy, histology), and to assess the need for an experienced abdominal radiologist versus a junior radiologist in performing accurate scoring.
Patients will be diagnosed with ovarian cancer in the standard manner. This includes assessment of symptoms, tumour markers, a CT scan, an ultrasound scan, histological or cytological testing and an exploratory laparoscopy. After this assessment, patients are deemed suitable for primary surgery or primary chemotherapy based on our ability to remove all of their disease. The management of patients will not change in this study. The only addition to management will be the addition of a diffusion weighted MRI scan prior to the exploratory laparoscopy. Patients will be consented for participation in the study at the outpatient clinic by a senior member of the team. The MRI scan will be done at the radiology department at the Mater Hospital.

The MRI scan will take up to 60 minutes. Patients will have intravenous and oral contrast for best visualisation of the colon. Standard comfort measures will be taken as for all MRI imaging. Each patient will continue with standard laparoscopic assessment of their disease and PCI scores from two radiologists will be compared to those taken by the surgeon intra-operatively.
Attachments [1] 2875 2875 0 0
/AnzctrAttachments/375501-MRI PCI ETHICS 030718 clean.docx (Protocol)
Attachments [2] 2876 2876 0 0
/AnzctrAttachments/375501-InformedConsent-mri study 030718 clean.doc (Participant information/consent)

Contacts
Principal investigator
Name 85062 0
Dr Sinead Barry
Address 85062 0
Mater Adults Hospital,
Gynaecological Cancer Centre,
Raymond Terrace,
South Brisbane,
QLD
4101
Country 85062 0
Australia
Phone 85062 0
+61 467970951
Fax 85062 0
Email 85062 0
[email protected]
Contact person for public queries
Name 85063 0
Dr Sinead Barry
Address 85063 0
Mater Adults Hospital,
Gynaecological Cancer Centre,
Raymond Terrace,
South Brisbane,
QLD
4101
Country 85063 0
Australia
Phone 85063 0
+61 467970951
Fax 85063 0
Email 85063 0
[email protected]
Contact person for scientific queries
Name 85064 0
Dr Sinead Barry
Address 85064 0
Mater Adults Hospital,
Gynaecological Cancer Centre,
Raymond Terrace,
South Brisbane
QLD
4101
Country 85064 0
Australia
Phone 85064 0
+61 467970951
Fax 85064 0
Email 85064 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
85Informed consent form    375501-(Uploaded-05-11-2018-17-21-46)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.