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Indo-cyanine green (ICG) is a dye that has been used for a variety of adult and paediatric uses since 1956. Over the past few years, near infrared (NIRF) technology has been developed which allow is use as a fluorescence agent during surgery. It has been used increasingly in the field of adult oncology surgery and has been shown to increase the efficacy of this surgery.
The aim of this study is to evaluate the use of NIRF and ICG during specific minimally invasive surgery (MIS) procedures within paediatric oncology surgery. Their use will complement existing surgical techniques rather than replace them.
Given the published advantages in adults this study aims to provide evidence of feasibility in the paediatric patients with cancer.
The purpose of this study is to show the feasibility of using ICG in combination with NIRF and MIS in paediatric oncology surgery. It has been used increasingly over the past few years for a range of adult oncology surgical indications including tumour margin identification, lymph node identification and pulmonary metastectomy. It will be investigated in three groups of patients in our study:
Modern radiology techniques can identify lesions as small as 1mm which are often not palpable at the time of surgery. Relying on finger palpation requires patients to have a thoracotomy with all of the associated complications. ICG will be injected intravenously and then NIRF will be combined with MIS to identify any fluorescent lesions. The location of any lesions will be compared with those seen on pre-surgical imaging (current standard practice).
For all three groups of patients, the use of ICG and NIRF will complement rather than replace existing surgical technique in patients who require surgery already. Data will be collected on the number of lesions which do/do not fluoresce as well as the histology of lesions removed. They will be separated into lesions which do not fluoresce, lesions which were removed before fluorescence (they will be checked for ex-vivo fluorescence) and fluorescing lesions so that the histological characteristics of each group can be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Injection of Indocyanine Green at doses detailed on summary of product characteristics for each age range |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug | Intravenous or intraparenchymal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of fluorescent nodes resected during minimally invasive tumour nephrectomy | Number of fluorescent nodes resected per patient | Until the end of surgery, 2 hours |
| Is Fluorescent guided tumour resection easier than non-fluorescent guided. | Subjective surgeon analysis of intra-operative conditions on a Likert scale per patient | until the end of surgery, 2 hours |
| To evaluate if NIRF and ICG allow detection of pulmonary metastases | Comparison of number of lesions seen on CT with those seen with fluoroscopy per patient | until the end of surgery, 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate if fluorescent nodes or metastases are more likely to contain viable tumour | Number of fluorescent nodes and metastases containing viable tumour per patient | until histopathology is reported, 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Max Pachl | Birmingham Women's and Children's NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham children's hospital | Birmingham | B4 6NH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34606881 | Derived | Pachl MJ. Fluorescent Guided Lymph Node Harvest in Laparoscopic Wilms Nephroureterectomy. Urology. 2021 Dec;158:189-192. doi: 10.1016/j.urology.2021.09.015. Epub 2021 Oct 2. |
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D012512 | Sarcoma, Ewing |
| D012208 | Rhabdomyosarcoma |
| D012509 | Sarcoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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open label, single centre, single arm, prospective feasibility study
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| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |