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

King's College London0 个研究点目标入组 5 人开始时间: 2015年11月20日最近更新: 2022年11月7日

适应症

试验速览

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

•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

•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

发起方