Patients with intermediate to high-grade bone or soft tissue sarcoma. Cancer
Conditions
Interventions
Patients of all ages with a histologically confirmed diagnosis of intermediate to high grade sarcoma will be screened for eligibility. Eligible patients will be randomised in a 1:1 ratio to standard o
interpretation of images and any influence on operative decision making is at the discretion of the operating surgeon. If fluorescence changes the procedure at any time, further images (in white light
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
0 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 21/04/2026: 1. Patients of any age 2. Capacity to provide written, informed consent (or parent/carer if <16 years of age; legal representative if an adult lacking capacity) 3. Histologically confirmed diagnosis of intermediate to high grade sarcoma 4. Amenable to surgical resection as a part of curative intent for the patient _____ Previous key inclusion criteria: 1. Patients of any age 2. Capacity to provide written, informed consent (or legal guardian if <16 years of age) 3. Histologically confirmed diagnosis of intermediate to high grade sarcoma 4. Amenable to curative surgical resection
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 21/04/2026: 1. Due for surgery with palliative intent 2. Recurrent tumours 3. Intracranial, retroperitoneal, and visceral anatomical locations 4. A woman of childbearing potential* who is currently pregnant (as confirmed by urine pregnancy test) 5. A woman who is currently breastfeeding 6. Known allergy to iodine, iodine dyes or shellfish. 7. Patients with hyper-thyroidism or autonomic thyroid adenomas 8. Premature infants/neonates with exchange transfusion indication due to hyperbilirubinemia 9. Previously known allergy or poor toleration of ICG _____ Previous key exclusion criteria: 1. Tumour not amenable to curative resection or recommended for non-operative management 2. Recurrent tumours 3. Intracranial, retroperitoneal and visceral anatomical locations 4. Females that are currently pregnant (as confirmed by urine pregnancy test) 5. Females who are currently breastfeeding 6. Known allergy to ICG, iodine, iodine dyes or shellfish. 7. Unable to provide written, informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The unexpected positive margin (UPM) rate, defined as the percentage of patients with an unexpected positive margin. The margin status of each tumour will be taken from the pathology report for each patient enrolled in the trial. This will be recorded at six months post-surgery and will be classified according to the R classification system. Positive margins will be classified as the visualisation of tumour cells at the inked margin and will then be classified as acceptable or unexpected. The UPM rate for each arm will be defined by calculating the percentage of patients in that arm with a UPM on histopathological assessment of the resection specimen. If a negative margin is recorded, the size of the closest margin should be recorded in millimetres | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key exclusion criteria as of 21/04/2026: Measured using patient records unless noted otherwise: 1. The difference in rate of AEs/SAEs reported between two groups 2. The difference in rate of ADEs/ SADEs reported between two groups 3. The difference in rates of surgery related AEs/SAEs reported between the two groups. 4. Between group differences in length of index operation measured in minutes 5. Difference in length of impatient stay in days 6. The percentage of operations in which the surgeon stated FGS changed their planned resection 7. The difference in rate of local recurrence at 12 months 8. The difference in rate of regional/distal recurrence at 12 months 9. The difference in rate of survival between the two groups 10. Adjuvant and neo-adjuvant therapy rates will include radiation therapy and/or chemotherapy. The type and frequency of therapy will be recorded 11. The difference in global and individual scores on EQ-5D-5L/EQ-5D-Y 12. The difference in scores on the Toronto extremity salvage score (TESS)/ Paediatric Toronto extremity salvage score (pTESS) Exploratory Outcomes 1. Fluorescence microscopy to assess extracellular and cellular ICG spatial orientation in tumour tissue versus surrounding normal tissues 2. Fluorescence mapping will be performed on all images taken during the trial and correlated with the pathological margin assessments _____ Previous key exclusion criteria: Measured using patient records unless noted otherwise: 1. Rates of intra- and postoperative complications as recorded in the clinical notes. 2. Length of operation in minutes 3. Length of inpatient stay in days. 4. The percentage of operations in which the surgeon stated FGS changed their planned resection. 5. Rate of local recurrence at 12 months. 6. Rate of regional/distal recurrence at 12 months. 7. Rate of overall survival at 12 months. 8. Rates of adjuvant and neo-adjuvant therapies as per clinical notes. 9. Quality of life measured using EQ-5D-5L/EQ-5D-Y at baseli | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public Contact- Newcastle Clinical Trials Unit
Outcome results
None listed