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

ISRCTN ISRCTN75827286
DOI https://doi.org/10.1186/ISRCTN75827286
EudraCT/CTIS number 2014-001925-33
Secondary identifying numbers 19094
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

Study designNon-randomised; Interventional; Design type: Not specified
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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 acronymBF4
Study objectivesThe 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) studiedTopic: Cancer; Subtopic: Head and Neck Cancer; Disease: Head and Neck
InterventionCannula inserted into each arm for the administration of the radioactive material and the taking of blood samples.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase I
Drug / device / biological / vaccine name(s)Tetrafluoroborate
Primary outcome measureTo assess the biodistribution of [18F]tetrafluoroborate in vivo
Secondary outcome measuresNot provided at time of registration
Overall study start date14/09/2015
Completion date02/08/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexBoth
Target number of participantsPlanned Sample Size: 20; UK Sample Size: 20
Total final enrolment5
Key inclusion criteria1. 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 criteria1. 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 enrolment14/09/2015
Date of final enrolment02/08/2017

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

King's College London
Hospital/treatment centre

Strand
London
WC2R 2LS
England
United Kingdom

ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

University/education

King's Health Partners

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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

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.