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Indo-cyanine Green (ICG) in Paediatric Oncology MIS

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ClinicalTrials.gov Identifier: NCT04854018
Recruitment Status : Not yet recruiting
First Posted : April 22, 2021
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Birmingham Women's and Children's NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pediatric Renal Tumor Metastatic Osteosarcoma Metastatic Ewing Sarcoma Pulmonary Metastasis Rhabdomyosarcoma Non-Rhabdo. Soft Tissue Sarcoma Drug: Indocyanine green Phase 4

Detailed Description:

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:

  1. Tumour margin identification-Identifying the margins of a tumour intra-operatively is crucial for many paediatric cancers. Incomplete resections or resections with involved margins often require upstaging of treatment with more intensive chemotherapy or radiotherapy. ICG will be injected intravenously and then NIRF will be used intermittently until fluorescence is achieved and an evaluation of the tumour and its margins will be performed.
  2. Lymph node identification - It is standard of care for most oncology resections to remove lymph nodes that are suspected to be involved with tumour. Both SIOP and COG recommend the removal of 7 or more lymph nodes during a nephrectomy for Wilm's tumour although this is often not achieved. IGC will be injected directly into the tumour (or the adjacent tissue in 2-4 places) and then NIRF will be used intermittently until fluorescence is achieved. An evaluation of the tumour and any fluorescent lymph nodes will then take place and any fluorescent lymph nodes will be removed.
  3. Pulmonary metastectomy - Many paediatric cancers including Wilm's tumour have a propensity to metastasise to the lungs. Removal of all lung metastases is important as it has the potential to down-stage tumours, obviating the need for pulmonary radiotherapy.

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open label, single centre, single arm, prospective feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single Centre, Single Arm, Prospective Feasibility Study Evaluating the Effectiveness of Near-infrared Fluorescence (NIRF) Using Indo-cyanine Green (ICG) in Minimally Invasive Paediatric Oncology Surgery (MIS)
Estimated Study Start Date : April 30, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022


Arm Intervention/treatment
Experimental: Single Arm
Injection of Indocyanine Green at doses detailed on summary of product characteristics for each age range
Drug: Indocyanine green
Intravenous or intraparenchymal injection
Other Names:
  • Verdye
  • Diagnostic Green




Primary Outcome Measures :
  1. Number of fluorescent nodes resected during minimally invasive tumour nephrectomy [ Time Frame: Until the end of surgery, 2 hours ]
    Number of fluorescent nodes resected per patient

  2. Is Fluorescent guided tumour resection easier than non-fluorescent guided. [ Time Frame: until the end of surgery, 2 hours ]
    Subjective surgeon analysis of intra-operative conditions on a Likert scale per patient

  3. To evaluate if NIRF and ICG allow detection of pulmonary metastases [ Time Frame: until the end of surgery, 2 hours ]
    Comparison of number of lesions seen on CT with those seen with fluoroscopy per patient


Secondary Outcome Measures :
  1. To evaluate if fluorescent nodes or metastases are more likely to contain viable tumour [ Time Frame: until histopathology is reported, 2 weeks ]
    Number of fluorescent nodes and metastases containing viable tumour per patient



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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 1 day and 15 years 365 days
  • Have a diagnosis of an intra-abdominal, retroperitoneal or intra-thoracic tumour or pulmonary metastases
  • Require surgery as part of their treatment
  • Tumour or metastasis suitable for MIS resection based on assessment of the pre-operative imaging

Exclusion Criteria:

  • Allergic to ICG
  • Allergic to iodine or iodides
  • Due to receive radioactive iodine as part of a treatment
  • Hyperthyroidism
  • Unwilling to participate
  • Chronic Kidney Disease stage V

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854018


Contacts
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Contact: Max Pachl, MB,ChB,FRCS +441213339381 max.pachl@nhs.net

Sponsors and Collaborators
Birmingham Women's and Children's NHS Foundation Trust
Investigators
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Principal Investigator: Max Pachl Birmingham Women's and Children's NHS Foundation Trust
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Responsible Party: Birmingham Women's and Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04854018    
Other Study ID Numbers: 20/BC/SME/PO/473
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Birmingham Women's and Children's NHS Foundation Trust:
Indocyanine green
Near Infra-red fluoroscopy
pediatric
oncology
minimal access surgery
Wilms
Additional relevant MeSH terms:
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Rhabdomyosarcoma
Sarcoma
Osteosarcoma
Sarcoma, Ewing
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Myosarcoma
Neoplasms, Muscle Tissue