Characterisation of kidney masses to identify cancer Cancer Renal cancer, malignant neoplasms of urinary tract, benign neoplasms
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients >18 years of age and less than 95 years 2. Renal tumour >2 cm identified on cross sectional imaging (CT or MRI) 3. Patients undergoing tumour biopsy, surgery or who have previously had a biopsy and are on active surveillance programmes 4. Capacity to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant, planning pregnancy or breastfeeding 2. Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 3 months of study enrolment 3. Multiple comorbidities which would make trial participation difficult (e.g. burden of an additional hospital visit) 4. Allergy to 99m Tc-sestamibi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of the 99mTc-sestamibi SPECT/CT scan to detect cancer reported by the nuclear medicine consultant (results will be matched with the histological tissue diagnosis, either by conventional tumour biopsy or surgery [the reference standard]) at a single timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability of 99mTc Sestamibi SPECT/CT scans in the diagnostic pathway of renal masses measured the Quality of Life questionnaire (EQ5DL) will given at screening (pre-treatment), as part of the first telephone assessment (day 15 + 2 days) and the second telephone assessment (day 28 + 14 days) | — |
Countries
England, United Kingdom