Can a nuclear medicine scan (MIBI) detect whether a mass in the kidney is cancer?

Not Applicable

Active, not recruiting

Conditions: Characterisation of kidney masses to identify cancer
Cancer
Renal cancer, malignant neoplasms of urinary tract, benign neoplasms

Registration Number: ISRCTN23705289

Lead Sponsor: niversity College London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 50

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

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)