Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000958280
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
6/06/2018
Date last updated
6/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Sentinel lymph node mapping in early stage endometrial cancer.
Scientific title
Sentinel lymph node mapping in early stage endometrial cancer using indocyanine green and near infra-red fluorescence imaging during minimally invasive surgery – review of technique in Queensland centres.
Secondary ID [1] 294098 0
None
Universal Trial Number (UTN)
U1111-1209-5892
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Endometrial cancer 306682 0
Condition category
Condition code
Cancer 305782 305782 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Sentinel lymph node mapping procedure using indocyanine green (ICG) fluorescent dye injected into the cervix and near infra-red fluorescence (NIRF) imaging during laparoscopic or robotic staging surgery for apparent early stage endometrial cancer,
All patients with apparent early stage endometrial cancer treated with surgery at Mater Hospital will undergo sentinel lymph node mapping as part of their staging surgery. This will involve injection of 4ml of ICG (1.25mg/ml) into the cervix after induction of anaesthesia and use of NIRF imaging with laparoscopic or robotic platform to visualise and remove sentinel lymph node(s) from each hemi-pelvis. The sentinel lymph nodes will be submitted to pathological ultra-staging. Data on primary tumour and sentinel lymph node detection, location and pathology findings will be recorded prospectively.

yes all patients currently undergo sentinel node mapping as standard care

patients will be followed up for 3 years (36 months). Patients will be reviewed post surgery in the usual manner to assess for recurrence of their disease.
Intervention code [1] 300376 0
Diagnosis / Prognosis
Comparator / control treatment
To assess whether sentinel lymph node status helps inform management decisions regarding adjuvant therapy, we will utilize comparative data from historical controls (treated according to staging protocol utilizing intra-operative frozen section), recorded on the Queensland Centre for Gynaecological Cancer (QCGC) database.

The historical data can be sourced at any time from the QCGC database. This database is the property of QCGC and was started to collect survival data on patients treated by our service. The data is readily available to us at any time. We will use control data from the past 10 years, from 1/01/2008 to 01/01/2018
Control group
Historical

Outcomes
Primary outcome [1] 304853 0
To assess the rates of SLN identification – per patient and per hemi-pelvis.
This will be collected from hospital records, using data recorded by the pathologist
Timepoint [1] 304853 0
One week post intervention:
Histopathology to identify the presence of mapped sentinel lymph nodes will be available 1 week post intervention. This will allow positive identification of mapped sentinel lymph nodes for each hemi-pelvis.
Primary outcome [2] 304854 0
To assess the sites of detected SLNs.
Timepoint [2] 304854 0
One week post intervention:
Histopathology to identify the presence of lymph tissue in the removed specimens will be available 1 week post intervention and this will confirm the presence/or not of true nodal tissue in the resected specimens.
Primary outcome [3] 304855 0
To assess the rate of successful removal of SLN – determined by the presence of nodal tissue on histopathological assessment of submitted specimen.
Timepoint [3] 304855 0
One week post intervention:
Histopathology to identify the presence of lymph tissue in the removed specimens will be available 1 week post intervention and this will confirm the presence/or not of true nodal tissue in the resected specimens. The rate of successful SLN collection will be calculated from this.
Secondary outcome [1] 343371 0
Intra-operative or post-operative complications related to SLN mapping / biopsy procedure.
Timepoint [1] 343371 0
follow up complications will be recorded up to 36 months at the review visits
Secondary outcome [2] 343372 0
Time interval between injection if ICG and commencement of pelvic side wall dissection and detection of SLN (recorded for each side of pelvis) to determine if there is an optimal time interval between injection and dissection which optimises detection rate.
Timepoint [2] 343372 0
intra-operative collection of the relevant times will be performed using a clock in theatre during the operation
Secondary outcome [3] 343373 0
Rate of patients deemed to have positive SLN based on routine histology (H&E staining)
Timepoint [3] 343373 0
One week post intervention:
Histopathology to identify the presence of lymph tissue in the removed specimens will be available 1 week post intervention and this will confirm the presence/or not of true nodal tissue in the SLN specimens.
Secondary outcome [4] 347770 0
Rate of patients deemed to have positive SLN based on ultra-staging (IHC).
Timepoint [4] 347770 0
One week post intervention:
Histopathology to identify the presence of lymph tissue in the removed specimens will be available 1 week post intervention and this will confirm the presence/or not of true nodal tissue in the SLN specimens. This will be compared to IHC data at a later stage.
Secondary outcome [5] 347784 0
To assess the laterality of SLNs
Timepoint [5] 347784 0
This information will be collected by the surgeon at the time of surgery and will be retrieved from the medical records.

Eligibility
Key inclusion criteria
- Clinically FIGO Stage 1 or Stage 2 disease (disease that is clinically and radiologically confined to the uterus with no evidence of nodal or distant metastatic disease).
- Patient over 18 years and able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current pregnancy or desire to retain fertility.
- Clinical or radiological evidence of extra-uterine disease including lymphadenopathy.
- Previous hysterectomy or treatment of endometrial cancer by radiotherapy, chemotherapy or hormonal therapy.
- Any contra-indication to comprehensive lymph-node staging.
- Patient declining any form of lymph node assessment or staging.
- Contra-indication to receiving indocyanine green dye including history of hepatic impairment or an iodine allergy.
- Inaccessible to follow-up.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Clinico-pathological characteristics will be evaluated using basic descriptive statistics.

The false positive rate is defined as zero. Overall and bilateral detection rates as well as sensitivity and false negative rate will be calculated using Fischer’s exact test.

The overall detection rate will be derived by dividing the number of procedures where at least one SLN is identified by the total number of procedures performed. The bilateral detection rate will be calculated by dividing the number of procedures where at least one SLN was identified on each side of the pelvis by the total number of procedures performed.

We will not be performing side specific lymphadenectomy in all patients, but rather restrict side specific lymphadenectomy to those patients that fail mapping and meet our current criteria for lymph node staging (grade 2 or 3 tumour, deep myoinvasion or bulky tumour >2cm diameter based on intra-operative frozen section). The false negative rate of SLN mapping will be calculated only or patients that undergo full pelvic lymphadenectomy after SLN mapping. False negative SLN mapping is defined as bilateral negative SLN or failed mapping bilaterally in combination with metastatic non-sentinel lymph nodes as determined by full pelvic lymph node dissection.

Rates of Stage 3 disease and prescription of adjuvant therapies between the SLN mapping cohort and historical controls will be calculated using a two sample t-test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/06/2018
Actual
Date of last participant enrolment
Anticipated
8/06/2020
Actual
Date of last data collection
Anticipated
5/06/2023
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10069 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 10880 0
Mater Private Hospital - South Brisbane
Recruitment postcode(s) [1] 21594 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 298733 0
Hospital
Name [1] 298733 0
Dept. Of Gynaecological Oncology Mater Adults Hospital
Country [1] 298733 0
Australia
Primary sponsor type
Hospital
Name
Dept. Of Gynaecological Oncology Mater Adults Hospital
Address
Raymond Terrace
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 297909 0
None
Name [1] 297909 0
Address [1] 297909 0
Country [1] 297909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299676 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 299676 0
Mater Research
Level 2
Aubigny Place
South Brisbane QLD 4101
Ethics committee country [1] 299676 0
Australia
Date submitted for ethics approval [1] 299676 0
23/02/2018
Approval date [1] 299676 0
14/05/2018
Ethics approval number [1] 299676 0
HREC/17/MHS/122

Summary
Brief summary
The purpose of this study is to determine the feasibility of an imaging technique in assessing the spread of cancer in women with cancer of the uterus.

Who is it for?
You may be eligible for this study if you are a female, over the age of 18, and have been diagnosed with Stage 1 or 2 cancer of the uterus.

Study details
All patients with early stage endometrial cancer at the Mater Adult Hospital in South Brisbane that are being treated with surgery will undergo sentinel lymph node mapping as part of their staging surgery.

The sentinel lymph nodes will then be submitted to the pathologist for analysis. Patients will not need to undergo further tests or follow ups after this.
There will be no special blood tests required for this study. All participants will have the routine bloods taken which are needed for surgery.

It is hoped that this research will show that sentinel lymph node mapping can safely replace traditional full pelvic lymph node removal in selected women with endometrial cancer.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2435 2435 0 0
/AnzctrAttachments/374550-SLN research protocol revision.docx (Protocol)
Attachments [2] 2436 2436 0 0
/AnzctrAttachments/374550-SLN Picf_interventional_self_version 1.doc (Participant information/consent)
Attachments [3] 2437 2437 0 0
/AnzctrAttachments/374550-APPENDIX A.docx (Supplementary information)
Attachments [4] 2438 2438 0 0
/AnzctrAttachments/374550-APPENDIX B.docx (Supplementary information)
Attachments [5] 2439 2439 0 0
/AnzctrAttachments/374550-Appendix C.docx (Supplementary information)
Attachments [6] 2440 2440 0 0
/AnzctrAttachments/374550-SLN STUDY FORMS.docx (Other)

Contacts
Principal investigator
Name 81258 0
Dr Nisha Jagasia
Address 81258 0
Dept of Gynaecological Oncology
Mater Hospital
Raymond Terrace
South Brisbane
QLD 4101
Country 81258 0
Australia
Phone 81258 0
+61 07 31638111
Fax 81258 0
+61 07 31632406
Email 81258 0
nisha.jagasia@mater.org.au
Contact person for public queries
Name 81259 0
Dr Nisha Jagasia
Address 81259 0
Dept of Gynaecological Oncology
Mater Hospital
Raymond Terrace
South Brisbane
QLD 4101
Country 81259 0
Australia
Phone 81259 0
+61 07 31638111
Fax 81259 0
Email 81259 0
nisha.jagasia@mater.org.au
Contact person for scientific queries
Name 81260 0
Dr Nisha Jagasia
Address 81260 0
Dept of Gynaecological Oncology
Mater Hospital
Raymond Terrace
South Brisbane
QLD 4101
Country 81260 0
Australia
Phone 81260 0
+61 07 31638111
Fax 81260 0
Email 81260 0
nisha.jagasia@mater.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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