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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75827286
Enrollment
20
Registered
2015-11-20
Start date
2015-09-14
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cancer

Interventions

Cannula inserted into each arm for the administration of the radioactive material and the taking of blood samples.

Sponsors

King's College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Not provided at time of registration

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026