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

Phase 1

Completed

• Conditions: Topic: Cancer; Subtopic: Head and Neck Cancer; Disease: Head and Neck; Cancer; Thyroid carcinoma

• Registration Number: ISRCTN75827286
• Lead Sponsor: King's College London

Brief Summary

2017 Results article in https://pubmed.ncbi.nlm.nih.gov/28385795/ results (added 07/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-20
• Study Completion: 2017-08-02
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 5

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration