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Trial registered on ANZCTR


Registration number
ACTRN12622001479796
Ethics application status
Approved
Date submitted
12/03/2022
Date registered
24/11/2022
Date last updated
24/11/2022
Date data sharing statement initially provided
24/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing MRI (magnetic resonance imaging) to diagnostic laparoscopy (keyhole surgery) in calculating a cancer burden and suitability for surgery in women with advanced ovarian cancer.
Scientific title
Diagnostic performance of diffusion-weighted MRI compared to laparoscopy in predicting feasibility of complete cytoreduction in advanced ovarian, fallopian tube and primary peritoneal cancer.
Secondary ID [1] 306670 0
2022/ETH01363
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian, fallopian tube and primary peritoneal cancer 325609 0
Condition category
Condition code
Cancer 322968 322968 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participant’s cases will be discussed at a gynaecological tumour board (at the participating hospitals of Chris O'Brien Lifehouse and Royal Women's Hospital), determining suitability for upfront cytoreduction versus neoadjuvant chemotherapy.

Participants for whom more clinical information or a tissue diagnosis is required will undergo diffusion-weighted magnetic resonance imaging (DW-MRI) (1 hour) and laparoscopy (30 minutes). The laparoscopy will occur within two weeks of the MRI. Two independent radiologists will calculate a PCI score, blinded from the other radiologist and the gynaecological oncological surgeon who subsequently performs the laparoscopically scored PCI. All PCI scores will be recorded and compared.

Participants recommended to have neoadjuvant chemotherapy (either at tumour board or post laparoscopy) will have routine NACT under the care of a medical oncologist. Following 2-3 cycles of NACT, imaging will be performed to determine if they are suitable for cytoreductive surgery. Routine standard of care would be imaging with a CT, whereas study participants will have a DW-MRI. Once again two independent radiologists will calculate a PCI score based on the participant’s DW-MRI, with the score being blinded from each other and the laparoscopic surgeon.

The only change to standard care is the addition of one, or possibly two, preoperative DW-MRI three weeks prior to major surgery and within two weeks of diagnostic laparoscopy. The timeframe is important to limit change to disease status between imaging and surgery.

Following surgery, participants will return to routine standard of care with completion of a further 2-3 cycles of chemotherapy and routine follow-up surveillance. Participants will be assessed at the time of imaging and at all subsequent follow-up visits for side effects secondary to participation in the study.
Intervention code [1] 323111 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330735 0
To determine if DW-MRI is equivalent to laparoscopy in:
1) Predicting PCI (peritoneal cancer index) [total score] found at CRS (cytoreductive surgery)
Timepoint [1] 330735 0
Cumulative data will be assessed at the conclusion of the study.
Primary outcome [2] 332618 0
To determine if DW-MRI is equivalent to laparoscopy in:
2) Predicting the ability to achieve minimal residual disease (less than or equal to 2.5mm) at CRS (cytoreductive surgery) for stage 3 ovarian cancer
Timepoint [2] 332618 0
Cumulative data will be assessed at the conclusion of the study.
Primary outcome [3] 333204 0
To determine if DW-MRI is equivalent to laparoscopy in:
1) Predicting PCI (peritoneal cancer index) found at CRS (cytoreductive surgery) within PCI regions
A diagram (such as that available on this website: http://www.psogi.com/opinion/calculating-the-peritoneal-cancer-index/) will be used for scoring of patients at both MRI and surgery. This will allow data collection on regions as well as an overall score, and hence enable comparison for both total scores and individual regions.
Timepoint [3] 333204 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [1] 407376 0
1) To determine the health economic difference (cost-benefit analysis) of DW-MRI compared to laparoscopy.

Cost data will be sourced from hospital financial records and data-linkage to the Medicare Benefits Scheme (MBS) database. Benefits will be determined by calculating quality-adjusted life years and comparing rates of complications between MRI, laparoscopy and laparotomy.
Timepoint [1] 407376 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [2] 414073 0
2) To determine adverse outcomes with DW-MRI and laparoscopy.
Adverse outcomes include contrast allergy, operative complications, infection and chemotherapy toxicity.
All participants will be assessed for adverse events (via verbal questioning and or clinical examination) at the time of MRI and at follow-up clinical appointments. Participants are advised to contact the research team if adverse events occur. Adverse events will be recorded and reviewed at monthly audits.
Timepoint [2] 414073 0
Operative complications will be assessed immediately post op and at the 6 week post operative review.
Chemotherapy toxicities are assessed prior to administration of each cycle (every 3 weeks).

Eligibility
Key inclusion criteria
1) Age greater than or equal to 18 years old
2) FIGO stage 3 ovarian cancer
3) Histologically or cytologically proven primary epithelial ovarian, primary peritoneal or fallopian tube carcinoma (including serous papillary adenocarcinoma, adenocarcinoma and endometrioid adenocarcinoma)
4) Willingness to provide written informed consent and participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Diagnosis other than ovarian cancer
2) Previous abdominal malignancy or tuberculosis
3) Severe claustrophobia
4) MR (magnetic resonance) contrast allergy
5) Hip replacement or spinal hardware
6) Renal failure of either acute or chronic nature which precludes contrast administration

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
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this research study is attempting to fill a gap in the literature, sample size estimation can be challenging. Paired t testing will be used to compare the PCI scores obtained radiologically and surgically. Using an online sample size calculator (https://statulator.com/SampleSize/ss2PM.html), 48 participants are required to achieve 80% power and a level of significance of 5% for detecting a mean difference of 5 (between the scores) and an expected standard deviation of 12. Therefore a sample size of 50 has been chosen for this study.
For statistical analysis, intraoperative PCI will be considered the gold standard. Sensitivity, specificity and accuracy will be calculated for each PCI region and PCI score overall. Analysis of continuous variables (such as the PCI scores of 0-39) will be performed with t-test and binary variables analysed with chi-square test. Regression analysis using the Bland-Altman method will be used to calculate bias and overall improvement in outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2022
Actual
Date of last participant enrolment
Anticipated
30/12/2024
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 21964 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [2] 21965 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 37058 0
2050 - Camperdown
Recruitment postcode(s) [2] 37059 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 311001 0
Other
Name [1] 311001 0
Chris O'Brien Lifehouse research philanthropy fund (for cost of MRIs at Lifehouse)
Country [1] 311001 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse (Sydney Local Health District)
Address
119-143 Missenden Rd,
Camperdown,
NSW 2050
Country
Australia
Secondary sponsor category [1] 312312 0
Hospital
Name [1] 312312 0
Royal Prince Alfred Hospital
Address [1] 312312 0
50 Missenden Rd,
Camperdown,
NSW 2050
Country [1] 312312 0
Australia
Secondary sponsor category [2] 313838 0
Hospital
Name [2] 313838 0
Royal Women's Hospital
Address [2] 313838 0
20 Flemington Rd,
Parkville,
Victoria 3052
Country [2] 313838 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310552 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310552 0
Ethics committee country [1] 310552 0
Australia
Date submitted for ethics approval [1] 310552 0
17/01/2022
Approval date [1] 310552 0
22/07/2022
Ethics approval number [1] 310552 0
2022/ETH01363

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118054 0
A/Prof Rhonda Farrell
Address 118054 0
Chris O'Brien Lifehouse
119-143 Missenden Rd
Camperdown
NSW 2050
Country 118054 0
Australia
Phone 118054 0
+61 2 8514 0262
Fax 118054 0
Email 118054 0
rhonda.farrell@lh.org.au
Contact person for public queries
Name 118055 0
Rhonda Farrell
Address 118055 0
Chris O'Brien Lifehouse
119-143 Missenden Rd
Camperdown
NSW 2050
Country 118055 0
Australia
Phone 118055 0
+61 2 8514 0262
Fax 118055 0
Email 118055 0
rhonda.farrell@lh.org.au
Contact person for scientific queries
Name 118056 0
Rhonda Farrell
Address 118056 0
Chris O'Brien Lifehouse
119-143 Missenden Rd
Camperdown
NSW 2050
Country 118056 0
Australia
Phone 118056 0
+61 2 8514 0262
Fax 118056 0
Email 118056 0
rhonda.farrell@lh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
If HREC approval is obtained for future studies, all of the individual participant data collected during the trial, after de-identification, will be available.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Only researchers who provide a methodologically sound proposal for future research and with HREC approval.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (rhonda.farrell@lh.org.au) and HREC.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15380Clinical study report    Open access once published (on completion of study... [More Details]



Results publications and other study-related documents

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