[18F]-tetrafluoroborate in patients with primary thyroid cancer or salivary cancer
ISRCTN | ISRCTN75827286 |
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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
Contact information
Dr Maite Jauregui-Osoro
Scientific
Scientific
King's College London
The Rayne Institute
4th Floor Lambeth Wing
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study information
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 |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
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 |
Completion date | 02/08/2017 |
Eligibility
Participant type(s) | Patient |
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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 |
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
- England
- United Kingdom
Study participating centre
St Thomas' Hospital
The Rayne Institute
4th Floor Lambeth Wing
Westminster Bridge Road
London
SE1 7EH
United Kingdom
4th Floor Lambeth Wing
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Sponsor information
King's College London
Hospital/treatment centre
Hospital/treatment centre
Strand
London
WC2R 2LS
England
United Kingdom
https://ror.org/0220mzb33 |
Funders
Funder type
University/education
King's Health Partners
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 |
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.