ANZCTR - Registration

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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

Secondary ID [1]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Diagnostic accuracy of deep bowel endometriosis as assessed by [18F]FES PET-CT compared with operative findings of deep bowel endometriosis

Timepoint [1]

Laparoscopy within 6 months of imaging.

Secondary outcome [1]

Diagnostic accuracy of deep bowel endometriosis as assessed by MRI compared with operative findings of deep bowel endometriosis

Timepoint [1]

Laparoscopy within 6 months of imaging.

Secondary outcome [2]

Diagnostic accuracy of deep bowel endometriosis as assessed by transvaginal ultrasound compared with operative findings of deep bowel endometriosis

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Nepean Hospital - Kingswood

Recruitment hospital [2]

Sydney Adventist Hospital - Wahroonga

Recruitment postcode(s) [1]

2747 - Kingswood

Recruitment postcode(s) [2]

2076 - Wahroonga

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Nepean Hospital

Address [1]

Derby St, Kingswood NSW 2747

Country [1]

Australia

Primary sponsor type

Hospital

Name

Nepean Hospital

Address

Derby St, Kingswood NSW 2747

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Nepean Blue Mountains Local Health District HREC

Ethics committee address [1]

Derby St, Kingswood NSW 2747

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/10/2019

Approval date [1]

06/07/2020

Ethics approval number [1]

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

A/Prof George Condous

Address

Nepean Hospital
Derby St,
Kingswood NSW 2747

Country

Australia

Phone

+61 2 4734 4777

Fax

george.condous@omnigynaecare.com.au

Contact person for public queries

Name

Bassem Gerges

Address

Norwest Obstetrics & Gynaecology
Suite 304, Q-Central, 10 Norbrik Drive
Bella Vista NSW 2153

Country

Australia

Phone

+61 2 8883 5143

Fax

reception@norwestobgyn.com.au

Contact person for scientific queries

Name

Bassem Gerges

Address

Norwest Obstetrics & Gynaecology
Suite 304, Q-Central, 10 Norbrik Drive
Bella Vista NSW 2153

Country

Australia

Phone

+61 2 8883 5143

Fax

reception@norwestobgyn.com.au

Data sharing statement

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

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.	Type	Attachment
7102	Study protocol	376688-(Uploaded-23-08-2020-23-55-51)-Study-related document.doc
7122	Informed consent form	376688-(Uploaded-23-08-2020-23-57-17)-Study-related document.doc
8914	Ethical 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.

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