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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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7 November 2022 |
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Main ID: |
ISRCTN75827286 |
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Date of registration:
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20/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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[18F]-tetrafluoroborate in patients with primary thyroid cancer or salivary cancer
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Scientific title:
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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 |
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Date of first enrolment:
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14/09/2015 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN75827286 |
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Study type:
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Interventional |
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Study design:
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Non-randomised; Interventional; Design type: Not specified (Treatment)
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Phase:
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Phase I
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Countries of recruitment
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England
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Maite
Jauregui-Osoro |
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Address:
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King's College London
The Rayne Institute
4th Floor Lambeth Wing
Westminster Bridge Road
SE1 7EH
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: Cancer; Subtopic: Head and Neck Cancer; Disease: Head and Neck
Cancer
Thyroid carcinoma
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Intervention(s)
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Cannula inserted into each arm for the administration of the radioactive material and the taking of blood samples.
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Primary Outcome(s)
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To assess the biodistribution of [18F]tetrafluoroborate in vivo
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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2014-001925-33
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19094
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Source(s) of Monetary Support
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King's Health Partners
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Ethics review
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Status:
Approval date:
Contact:
London - Surrey Borders Research Ethics Committee, 29/12/2014, ref: 14/LO/1247
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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02/08/2017 |
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URL:
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