[18F]-tetrafluoroborate in patients with primary thyroid cancer or salivary cancer

ISRCTN	ISRCTN75827286
DOI	https://doi.org/10.1186/ISRCTN75827286
Clinical Trials Information System (CTIS)	2014-001925-33
Protocol serial number	19094
Sponsor	King's College London
Funder	King's Health Partners

Submission date: 19/11/2015
Registration date: 20/11/2015
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-using-pet-ct-scans-to-detect-thyroid-cancer-and-salivary-gland-cancer

Contact information

Dr Maite Jauregui-Osoro
Scientific

King's College London
The Rayne Institute
4th Floor Lambeth Wing
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Non-randomised; Interventional; Design type: Not specified
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific 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
Study acronym	BF4
Study objectives	The aim of this study is to investigate whether tetrafluoroborate has any side effects and if it specifically targets cancers that express the hNIS transporter.
Ethics approval(s)	London - Surrey Borders Research Ethics Committee, 29/12/2014, ref: 14/LO/1247
Health condition(s) or problem(s) studied	Topic: Cancer; Subtopic: Head and Neck Cancer; Disease: Head and Neck
Intervention	Cannula inserted into each arm for the administration of the radioactive material and the taking of blood samples.
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	Tetrafluoroborate
Primary outcome measure(s)	To assess the biodistribution of [18F]tetrafluoroborate in vivo
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	02/08/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	20
Total final enrolment	5
Key inclusion criteria	1. Aged 18-80 years 2. Women of childbearing potential must have documented negative pregnancy test on day 1, prior to (18F)BF4-administration 3. Diagnosis of a malignancy of the thyroid or a malignancy of a salivary gland 4. All patients have to be suitable for surgical treatment as part of their normal management 5. Able to comply with treatment plans, scheduled visits, all study PET imaging and follow-up 6. Willing to give informed consent 7. Not be taking thyroid mediciation or iodine containing medication
Key exclusion criteria	1. Previous ionising radiation exposure for research purposes or exposure to any previous experimental medicine that might affect the uptake of BF4 would exclude the patient from this ionising radiation study 2. Patients without adequate understanding of written or spoken English would not be able to participate in this study as translation of the patient information sheet will not be possible 3. Any prior treatment for the thyroid or salivary gland tumours 4. Pregnancy or lactation 5. Any other problems that may make the patient unable to tolerate the PET scans or translational biopsies 6. Ingestion of iodine containing medication (eg amiodarone) within preceding 12 months, administration of iv contrast media within 6 months or thyroid hormones within 2 months
Date of first enrolment	14/09/2015
Date of final enrolment	02/08/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

St Thomas' Hospital

The Rayne Institute
4th Floor Lambeth Wing
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	06/04/2017	07/08/2020	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results		26/07/2021	29/07/2021	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English summary link and total final enrolment added.
29/07/2021: Cancer Research UK plain English results link added.
07/08/2020: Publication reference added.