Additional identifiers
EudraCT/CTIS number
2014-001925-33
IRAS number
ClinicalTrials.gov number
Protocol/serial number
19094
Study information
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
Acronym
BF4
Study hypothesis
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
Study design
Non-randomised; Interventional; Design type: Not specified
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Pharmaceutical study type(s)
Phase
Phase I
Drug/device/biological/vaccine name(s)
Tetrafluoroborate
Primary outcome measure
To assess the biodistribution of [18F]tetrafluoroborate in vivo
Secondary outcome measures
Not provided at time of registration
Overall study start date
14/09/2015
Overall study end date
02/08/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
80 Years
Sex
Both
Target number of participants
Planned Sample Size: 20; UK Sample Size: 20
Total final enrolment
5
Participant 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
Recruitment start date
14/09/2015
Recruitment end date
02/08/2017
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
St Thomas' Hospital
The Rayne Institute
4th Floor Lambeth Wing
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
King's College London
Sponsor details
Strand
London
WC2R 2LS
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
University/education
Funder name
King's Health Partners
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
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 |
| Plain English results | 26/07/2021 | 29/07/2021 | No | Yes | |
| HRA research summary | 28/06/2023 | No | No |