BF4
Research type
Research Study
Full title
A phase I trial of [18F]-tetrafluoroborate in patients with primary thyroid cancer or salivary cancer to study biodistribution and uptake in tumours and normal NIS expressing tissue.
IRAS ID
117263
Contact name
Valerie Lewington
Contact email
Sponsor organisation
King's College London
Eudract number
2014-001925-33
Research summary
Thyroid carcinoma is the most common endocrine malignancy, with an estimated incidence of 7.7 per 100,000. The incidence has risen globally over the past 2 decades,with papillary carcinoma showing the greatest proportional increase over time. Thyroid carcinomas comprise a heterogenous group of tumours characterised by different clinical features and outcomes. Differentiated thyroid carcinomas include papillary, follicular and Hurthle cell carcinomas which take up iodine by a transporter called hNIS. These tumours have a good prognosis when treated using surgical removal and radioactive iodine treatment but prompt identification of local or distant spread is critical. We are investigating a new radioactive molecule called tetrafluoroborate that can be imaged using a PET-CT scanner to determine whether the cancer has spread in the body. This study is intended to confirm that the tetrafluoroborate has no side effects and that it specifically targets cancers that express the hNIS transporter. If successful, this technique is likely to have a higher detection rate for thyroid cancer than conventional radioactive iodine imaging and will, therefore, allow rapid assessment necessary to guide treatment in patients with this type of thyroid cancer. The hNIS transporter is also expressed in other tissues such as the salivary glands and we will also examine the role of tetrafluoroborate in patients with salivary gland tumours. The pilot study in these two tumour groups will allow assessment of the whole body radiation dose from the radiaoctive tracer before proceeding to a larger patient study. The patients' tumours will be removed as part of their normal treatment. The amount of the hNIS transporter in normal and abnormal tissues will be measured histologically and related to the uptake of tetrafluoroborate in the tumours on the PET CT scans.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
14/LO/1247
Date of REC Opinion
29 Dec 2014
REC opinion
Further Information Favourable Opinion