Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000940976
Ethics application status
Approved
Date submitted
26/02/2020
Date registered
21/09/2020
Date last updated
21/09/2020
Date data sharing statement initially provided
21/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Diagnostic accuracy of transvaginal ultrasound, magnetic resonance imaging and positron emission tomography-computed tomography with 16a-[18F]fluoro-17ß-estradiol for the diagnosis of rectosigmoid deep endometriosis
Scientific title
Diagnostic accuracy of transvaginal ultrasound, magnetic resonance imaging and positron emission tomography-computed tomography with 16a-[18F]fluoro-17ß-estradiol for the diagnosis of rectosigmoid deep endometriosis
Secondary ID [1] 297022 0
Nil
Universal Trial Number (UTN)
U1111-1248-8097
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Deep Endometriosis 316452 0
Condition category
Condition code
Reproductive Health and Childbirth 314703 314703 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A history will be obtained and clinical examination performed on all women by gynaecologists/gynaecology fellows/registrars. Examination will include determination of site-specific tenderness and this will be measured using a verbal analogue score. A 2D transvaginal ultrasound (TVUS) with Doppler will be performed during this appointment by a gynaecology/gynaecology fellow to assess the pelvis for concurrent pathology as well as assessing for POD obliteration and site-specific tenderness (this will be measured using a verbal analogue score). Next, an endometriosis scan will be performed to visualise the posterior pelvic compartment for the identification of deep infiltrating endometriosis.

Women who have suspected bowel DE on TVUS (approx 20 min duration) will then undergo MRI (approx 30 min duration) and PET-CT using the isotope 16a-[18F]fluoro-17ß-estradiol (approx 30 min duration), administered by a nuclear medicine radiologist who will administer a weight-dependent, reduced tracer dose as well as a limited low radiation dose CT. The trial committee will comply with the recommendations outlined in the radiation safety officers report. Every effort will be made to ensure patient doses are consistent with the ALARA principle, within the boundaries outlined in the trial guidelines. Both MRI and PET-CT will be scheduled on the same day with all imaging modalities being performed within 6 months of surgery.
MRI and PET-CT studies will be reviewed by two independent radiologists, blinded to the TVUS findings. If any incidental lesions are identified, a follow-up appointment for the study participant will be organised, during which they will be counselled regarding the findings and the appropriate referrals made.

The MRI protocol on 1.5T involves
• Axial, coronial, sagittal T2 weighted sequences;
• Axial, sagittal T1 fat sat sequences; and
• Axial sagittal SWI sequences
In the event that a woman has an intra-uterine device, the metal-containing (gold/copper) and metal-free (Mirenas) IUDs and ESSURE are compatible with 1.5 T MRI. Stainless steel IUDs (used overseas in 1980s up till 2000) are not MRI compatible but unlikely to be in the population studied. Gadolinium will not be given.
Intervention code [1] 316987 0
Diagnosis / Prognosis
Comparator / control treatment
No control group - only women with suspected deep bowel endometriosis will be included in this pilot study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323042 0
Diagnostic accuracy of deep bowel endometriosis as assessed by [18F]FES PET-CT compared with operative findings of deep bowel endometriosis
Timepoint [1] 323042 0
Laparoscopy within 6 months of imaging.
Secondary outcome [1] 380608 0
Diagnostic accuracy of deep bowel endometriosis as assessed by MRI compared with operative findings of deep bowel endometriosis
Timepoint [1] 380608 0
Laparoscopy within 6 months of imaging.
Secondary outcome [2] 386077 0
Diagnostic accuracy of deep bowel endometriosis as assessed by transvaginal ultrasound compared with operative findings of deep bowel endometriosis
Timepoint [2] 386077 0
Laparoscopy within 6 months.

Eligibility
Key inclusion criteria
All women of reproductive age booked for laparoscopic excision of endometriosis with suspected bowel DE.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
– Malignancy
– Menopause
– Pregnancy

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 analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this study, we will perform TVUS, MRI and PET-CT with [18F]FES on 20 women with suspected bowel DE on TVUS preoperatively in order to compare the diagnostic accuracy of these imaging modalities for the presence or absence of bowel DE.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2020
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)
NSW
Recruitment hospital [1] 15991 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 15992 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 29490 0
2747 - Kingswood
Recruitment postcode(s) [2] 29491 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 301592 0
Hospital
Name [1] 301592 0
Nepean Hospital
Country [1] 301592 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Derby St, Kingswood NSW 2747
Country
Australia
Secondary sponsor category [1] 305456 0
None
Name [1] 305456 0
Address [1] 305456 0
Country [1] 305456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302320 0
Nepean Blue Mountains Local Health District HREC
Ethics committee address [1] 302320 0
Derby St, Kingswood NSW 2747
Ethics committee country [1] 302320 0
Australia
Date submitted for ethics approval [1] 302320 0
28/10/2019
Approval date [1] 302320 0
06/07/2020
Ethics approval number [1] 302320 0
2019/ETH13390

Summary
Brief summary
Although 5-10% of women with endometriosis will have bowel involvement, currently it is very difficult to predict this group preoperatively. This group of women require both gynaecological and colorectal input at surgery. Preoperative imaging is being increasingly utilised to predict the level of complexity of laparoscopic surgery for endometriosis. It has the potential to facilitate the triage of women with suspected bowel deep endometriosis (DE) to the most appropriate surgical expertise required for laparoscopic intervention for endometriosis.

Transvaginal ultrasound (TVUS) (Guerriero S, et al. UOG, 2016) and magnetic resonance imaging (MRI) (Medeiros, et al. Arch Gyn Obs, 2015) have been shown to accurately diagnose the presence of rectosigmoid DE. Recently, positron emission tomography-computed tomography (PET-CT) with 16a-[18F]fluoro-17ß-estradiol ([18F]FES) has had promising results when compared with MRI.

The study would be a prospective observational pilot study on women who present with suspected bowel DE diagnosed on TVUS and a plan for laparoscopic endometriosis surgery. Women would undergo a detailed history and clinical examination including a specialized TVUS, MRI and PET-CT with [18F]FES in a tertiary referral unit prior to laparoscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89810 0
A/Prof George Condous
Address 89810 0
Nepean Hospital
Derby St,
Kingswood NSW 2747
Country 89810 0
Australia
Phone 89810 0
+61 2 4734 4777
Fax 89810 0
Email 89810 0
[email protected]
Contact person for public queries
Name 89811 0
Dr Bassem Gerges
Address 89811 0
Norwest Obstetrics & Gynaecology
Suite 304, Q-Central, 10 Norbrik Drive
Bella Vista NSW 2153
Country 89811 0
Australia
Phone 89811 0
+61 2 8883 5143
Fax 89811 0
Email 89811 0
[email protected]
Contact person for scientific queries
Name 89812 0
Dr Bassem Gerges
Address 89812 0
Norwest Obstetrics & Gynaecology
Suite 304, Q-Central, 10 Norbrik Drive
Bella Vista NSW 2153
Country 89812 0
Australia
Phone 89812 0
+61 2 8883 5143
Fax 89812 0
Email 89812 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
These will include personal histories and health information that is not appropriate for sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7102Study protocol    376688-(Uploaded-23-08-2020-23-55-51)-Study-related document.doc
7122Informed consent form    376688-(Uploaded-23-08-2020-23-57-17)-Study-related document.doc
8914Ethical approval    376688-(Uploaded-24-08-2020-00-00-02)-Study-related document.pdf



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.