Condition category
Cancer
Date applied
19/11/2015
Date assigned
20/11/2015
Last edited
20/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review by external organisation.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maite Jauregui-Osoro

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2014-001925-33

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

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

Trial setting

Other

Trial 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

Phase

Phase I

Drug names

Tetrafluoroborate

Primary outcome measures

To assess the biodistribution of [18F]tetrafluoroborate in vivo

Secondary outcome measures

Not provided at time of registration

Overall trial start date

14/09/2015

Overall trial end date

02/08/2017

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes