Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000015549
Ethics application status
Approved
Date submitted
19/11/2023
Date registered
10/01/2024
Date last updated
14/06/2024
Date data sharing statement initially provided
10/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Application of the fluorescent dye 'indocyanine green': Does it improve the quality of surgery for patients with oesophageal and stomach cancer?
Scientific title
Application of indocyanine green in gastric and oesophageal cancer patients (ICG-GO): Investigating the impact on quality of surgery
Secondary ID [1] 310992 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
ICG-GO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal cancer 332094 0
Gastric cancer 332095 0
Condition category
Condition code
Cancer 328816 328816 0 0
Oesophageal (gullet)
Cancer 328817 328817 0 0
Stomach
Surgery 328818 328818 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a multi-centre prospective cohort study (interventional) assessing if indocyanine-green can increase lymph node yield during surgery for oesophageal and gastric cancer.
Indocyanine green is a water soluble, tricarbocyanine dye with peak spectral absorption at 800 nm.
The chemical name for Indocyanine green is 1 H-Benz[e]indolium,2-[7[1,3-dihydro-1,1-dimethyl-3-(-4-sulfobutyl)-2H-benz[e]indo-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-,hydroxide, innersalt, sodium. 2-[7-[1,1-Dimethyl-3-(4-sulfobuttyl)benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl]-1,1-dimethyl-3-(4-sulfobutyl)-1Hbenz[e]indolium hydroxide.
Indocyanine green is approved by the FDA and is accessible for intra-operative diagnostic use in Australia under the TGA special access scheme.
During the intervention phase, all participants will receive ICG on the day of surgery.
Indocyanine green is administered at the commencement of surgery via endoscopy. A surgeon trained to perform the procedure will administer indocyanine green.
A single delivery of four 0.5ml injections of 0.312mg/ml indocyanine green (total of 0.625mg) is administered submucosally around the tumour in quadrants.
Indocyanine green will diffuse to lymph nodes via lymphatic channels. At the conclusion of standard of care surgery, a near-infrared camera will be used to identify and remove any additional lymph nodes containing ICG in the surgical field. The number of additional nodes identified with indocyanine green will be compared to the number of lymph nodes removed without indocyanine green identification and analysed for the presence of metastasis.
Routine surgery, depending on the case type is anticipated to take between 4-6 hours. The use of ICG and indocyanine green is anticipated to add 15 minutes to the overall case.
Strategies to monitor adherence to the intervention include review of operative photos that will be taken of the surgical field and the specimen at the end of routine surgery, and the operation report.
Intervention code [1] 327434 0
Treatment: Surgery
Comparator / control treatment
No control group. The comparator is the number of lymph nodes removed before the use of a near-infrared camera to identify and remove any additional lymph nodes containing indocyanine green in the surgical field.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336621 0
The primary endpoint for the study is whether there is difference in lymph node yield before and after the detection of ICG.
Timepoint [1] 336621 0
The outcome will be assessed upon obtaining the final pathology report at 14 days post surgery (+/-7 days).
Secondary outcome [1] 429027 0
Secondary outcome 1 is the metastasis detection rate within ICG LN (including Sensitivity and Specificity etc) .This will be determined by pathological analysis of lymph nodes that are labelled as “ICG hot”.
Timepoint [1] 429027 0
The outcome will be assessed upon obtaining the final pathology report at 14 days post surgery (+/-7 days).
Secondary outcome [2] 429981 0
Secondary outcome 2 is the detection rate of the ICG control node. The (positive) control node is defined as lymph node that is expected to fluouresce when ICG is injected peri-tumourally relative to the location of the tumour.
Timepoint [2] 429981 0
Secondary outcome 2 will be determined on the day of surgery

Eligibility
Key inclusion criteria
1. Patients with cancers of the oesophagus, gastro-oesophageal junction and stomach who are undergoing curative-intent surgery.
2. Patients undergoing the following operations:
• Ivor-Lewis (two-stage) oesophagectomy
• McKeown (three-stage) oesophagectomy
• Proximal partial oesophago-gastrectomy
• Extended total gastrectomy
• Total gastrectomy
• Subtotal gastrectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient declined participation in study
2. Known allergy to indocyanine green, sodium iodide or iodine.
3. Evidence of thyroid nodules on physical examination or on standard of care staging PET/CT scan
4. Biochemical evidence of hyperthyroidism from thyroid function tests (TFT)
5. Patient’s receiving concurrent radioactive iodine treatment for thyroid disease
6. Patients with Stage IV cancer (AJCC 8th edition)
7. Stage IV and V kidney failure
8. Pregnancy and breastfeeding

Study design
Purpose of the study
Treatment
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
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/03/2024
Actual
8/04/2024
Date of last participant enrolment
Anticipated
3/02/2025
Actual
Date of last data collection
Anticipated
17/02/2025
Actual
Sample size
Target
40
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25871 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 25872 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 41704 0
3000 - Melbourne
Recruitment postcode(s) [2] 41705 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 315256 0
Commercial sector/Industry
Name [1] 315256 0
Stryker Australia
Country [1] 315256 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan St, Melbourne Victoria 3000
Country
Australia
Secondary sponsor category [1] 317288 0
None
Name [1] 317288 0
Address [1] 317288 0
Country [1] 317288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314173 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 314173 0
305 Grattan Street, Melbourne, Victoria, 3000
Ethics committee country [1] 314173 0
Australia
Date submitted for ethics approval [1] 314173 0
13/11/2023
Approval date [1] 314173 0
25/01/2024
Ethics approval number [1] 314173 0
HREC/103336/PMCC

Summary
Brief summary
This study will assess the use of a dye (indocyanine green or ICG) to identify lymph nodes within the oesophagus and stomach during surgery to remove lymph nodes in patients with stomach and/or oesophageal cancer.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with oesophagus, gastro-oesophageal junction and/or stomach cancer and you will be undergoing surgery as the primary treatment for your cancer.

Study details
All participants who choose to enrol in this study will have an additional step of a dye injection (ICG) at the start of surgery. The planned surgery will then be conducted as per usual process with as many lymph nodes removed as are identified. At the end of the surgery, the surgeon will then use a near-infrared camera to scan the tissue to identify and remove any additional lymph nodes containing ICG in the surgical field.

It is hoped this research will determine whether a greater number of lymph nodes can be identified and removed with the ICG dye and camera scanning compared to usual care. If this method is found to be more successful at identifying and removing lymph nodes for patients with oesophageal and stomach cancers, it may be included in the usual care practices to improve outcomes for future cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130674 0
A/Prof Cuong Duong
Address 130674 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne Vic 3000
Country 130674 0
Australia
Phone 130674 0
+61 0409250903
Fax 130674 0
Email 130674 0
cuong.duong@petermac.org
Contact person for public queries
Name 130675 0
Dr Michael Bozin
Address 130675 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne Vic 3000
Country 130675 0
Australia
Phone 130675 0
+61 0422159169
Fax 130675 0
Email 130675 0
mike.bozin@petermac.org
Contact person for scientific queries
Name 130676 0
Dr Michael Bozin
Address 130676 0
Peter MacCallum Cancer Centre, 305 Grattan St, Melbourne Vic 3000
Country 130676 0
Australia
Phone 130676 0
+61 0422159169
Fax 130676 0
Email 130676 0
mike.bozin@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.