Dataset Information

Protocol for a MULTI-centre feasibility study to assess the use of ^99mTc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study).

ABSTRACT:

Introduction

The incidence of renal tumours is increasing and anatomic imaging cannot reliably distinguish benign tumours from renal cell carcinoma. Up to 30% of renal tumours are benign, with oncocytomas the most common type. Biopsy has not been routinely adopted in many centres due to concerns surrounding non-diagnostic rate, bleeding and tumour seeding. As a result, benign masses are often unnecessarily surgically resected. ^99mTc-sestamibi SPECT/CT has shown high diagnostic accuracy for benign renal oncocytomas and other oncocytic renal neoplasms of low malignant potential in single-centre studies. The primary aim of MULTI-MIBI is to assess feasibility of a multicentre study of ^99mTc-sestamibi SPECT/CT against a reference standard of histopathology from surgical resection or biopsy. Secondary aims of the study include obtaining estimates of ^99mTc-sestamibi SPECT/CT sensitivity and specificity and to inform the design and conduct of a future definitive trial.

Methods and analysis

A feasibility prospective multicentre study of participants with indeterminate, clinical T1 renal tumours to undergo ^99mTc-sestamibi SPECT/CT (index test) compared with histopathology from biopsy or surgical resection (reference test). Interpretation of the index and reference tests will be blinded to the results of the other. Recruitment rate as well as estimates of sensitivity, specificity, positive and negative predictive value will be reported. Semistructured interviews with patients and clinicians will provide qualitative data to inform onward trial design and delivery. Training materials for ^99mTc-sestamibi SPECT/CT interpretation will be developed, assessed and optimised. Early health economic modelling using a decision analytic approach for different diagnostic strategies will be performed to understand the potential cost-effectiveness of ^99mTc-sestamibi SPECT/CT.

Ethics and dissemination

Ethical approval has been granted (UK HRA REC 20/YH/0279) protocol V.5.0 dated 21/6/2022. Study outputs will be presented and published nationally and internationally.

Trial registration number

ISRCTN12572202.

SUBMITTER: Warren H

PROVIDER: S-EPMC9884914 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Protocol for a MULTI-centre feasibility study to assess the use of <sup>99m</sup>Tc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study).

Warren Hannah H Wagner Thomas T Gorin Michael A MA Rowe Steven S Holman Beverley Fiona BF Pencharz Deborah D El-Sheikh Soha S Barod Ravi R Patki Prasad P Mumtaz Faiz F Bex Axel A Kasivisvanathan Veeru V Moore Caroline M CM Campain Nicholas N Cartledge Jon J Scarsbrook Andrew A Hassan Fahim F O'Brien Tim S TS Stewart Grant D GD Mendichovszky Iosif I Dizdarevic Sabina S Alanbuki Ammar A Wildgoose William H WH Wah Tze T Vindrola-Padros Cecilia C Pizzo Elena E Dehbi Hakim-Moulay HM Lorgelly Paula P Gurusamy Kurinchi K Emberton Mark M Tran Maxine G B MGB

BMJ open 20230124 1

<h4>Introduction</h4>The incidence of renal tumours is increasing and anatomic imaging cannot reliably distinguish benign tumours from renal cell carcinoma. Up to 30% of renal tumours are benign, with oncocytomas the most common type. Biopsy has not been routinely adopted in many centres due to concerns surrounding non-diagnostic rate, bleeding and tumour seeding. As a result, benign masses are often unnecessarily surgically resected. <sup>99m</sup>Tc-sestamibi SPECT/CT has shown high diagnostic ...[more]

PMID: 36693694

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Project description:BackgroundMolecular breast imaging (MBI) performed with 99mTc sestamibi has been shown to be a valuable technique for the detection of breast cancer. Alternative radiotracers such as 99mTc maraciclatide may offer improved uptake in breast lesions. The purpose of this study was to compare relative performance of 99mTc sestamibi and 99mTc maraciclatide in patients with suspected breast cancer, using a high-resolution dedicated gamma camera for MBI. Women with breast lesions suspicious for malignancy were recruited to undergo two MBI examinations-one with 99mTc sestamibi and one with 99mTc maraciclatide. A radiologist interpreted MBI studies in a randomized, blinded fashion to assign an assessment score (1-5) and measured lesion size. Lesion-to-background (L/B) ratio was measured with region-of-interest analysis.ResultsAmong 39 analyzable patients, 21 malignant tumors were identified in 21 patients. Eighteen of 21 tumors (86%) were seen on 99mTc sestamibi MBI and 19 of 21 (90%) were seen on 99mTc maraciclatide MBI (p = 1). Tumor extent measured with both radiopharmaceuticals correlated strongly with pathologic size (99mTc sestamibi, r = 0.84; 99mTc maraciclatide, r = 0.81). The L/B ratio in detected breast cancers was similar for the two radiopharmaceuticals: 1.55 ± 0.36 (mean ± S.D.) for 99mTc sestamibi and 1.62 ± 0.37 (mean ± S.D.) for 99mTc maraciclatide (p = 0.53). No correlation was found between the L/B ratio and molecular subtype for 99mTc sestamibi (r s = 0.12, p = 0.63) or 99mTc maraciclatide (r s = -0.12, p = 0.64). Of 20 benign lesions, 10 (50%) were seen on 99mTc sestamibi and 9 of 20 (45%) were seen on 99mTc maraciclatide images (p = 0.1). The average L/B ratio for benign lesions was 1.34 ±0.40 (mean ±S.D.) for 99mTc sestamibi and 1.41 ±0.52 (mean ±S.D.) for 99mTc maraciclatide (p = 0.75). Overall diagnostic performance was similar for both radiopharmaceuticals. AUC from ROC analysis was 0.83 for 99mTc sestamibi and 0.87 for 99mTc maraciclatide (p = 0.64).Conclusions99mTc maraciclatide offered comparable lesion uptake to 99mTc sestamibi, in both malignant and benign lesions. There was good correlation between lesion extent and uptake measured from both radiopharmaceuticals. 99mTc maraciclatide offered a marginal (but not significant) improvement in sensitivity over 99mTc sestamibi. Our findings did not support an association between the uptake of either radiopharmaceutical and tumor molecular subtype.Trial registrationClinicalTrials.gov, NCT00888589.

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Dataset Information

Protocol for a MULTI-centre feasibility study to assess the use of ^99mTc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study).

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Protocol for a MULTI-centre feasibility study to assess the use of <sup>99m</sup>Tc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Protocol for a MULTI-centre feasibility study to assess the use of 99mTc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study).

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Protocol for a MULTI-centre feasibility study to assess the use of <sup>99m</sup>Tc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Protocol for a MULTI-centre feasibility study to assess the use of ^99mTc-sestaMIBI SPECT/CT in the diagnosis of kidney tumours (MULTI-MIBI study).