ANZCTR - Registration

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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]

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

Condition category

Condition code

Cancer

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]

Diagnosis / Prognosis

Comparator / control treatment

No Control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

assess the extent of cancer assessed by Peritoneal Cancer Index (PCI) using MRI

Timepoint [1]

Surgically score PCI will occur in theatre and Radiologically scored PCI will occur up to a week before surgery.

Primary outcome [2]

assess the extent of cancer seen at surgery assessed Peritoneal Cancer Index (PCI) determined by surgeon

Timepoint [2]

Surgically score PCI will occur in theatre

Secondary outcome [1]

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]

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?

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]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Mater Foundation

Address [1]

Mater Adults Hospital,
Aubigny Place
South Brisbane
QLD
4101

Country [1]

Australia

Primary sponsor type

Hospital

Name

Mater Adults Hospital

Address

Raymond Terrace, South Brisbane, QLD, 4101

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Misericordiae Ltd Human Research Ethics Committee [EC00332].

Ethics committee address [1]

Mater Adults Hospital
Raymond Terrace 
South Brisbane
Qld
4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/05/2018

Approval date [1]

23/07/2018

Ethics approval number [1]

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]

/AnzctrAttachments/375501-MRI PCI ETHICS 030718 clean.docx (Protocol)

Attachments [2]

/AnzctrAttachments/375501-InformedConsent-mri study 030718 clean.doc (Participant information/consent)

Contacts

Principal investigator

Name

Dr Sinead Barry

Address

Mater Adults Hospital,
Gynaecological Cancer Centre,
Raymond Terrace,
South Brisbane,
QLD
4101

Country

Australia

Phone

+61 467970951

Fax

sineadcbarry@gmail.com

Contact person for public queries

Name

Sinead Barry

Address

Mater Adults Hospital,
Gynaecological Cancer Centre,
Raymond Terrace,
South Brisbane,
QLD
4101

Country

Australia

Phone

+61 467970951

Fax

sineadcbarry@gmail.com

Contact person for scientific queries

Name

Sinead Barry

Address

Mater Adults Hospital,
Gynaecological Cancer Centre,
Raymond Terrace,
South Brisbane
QLD
4101

Country

Australia

Phone

+61 467970951

Fax

sineadcbarry@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
85	Informed 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.

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