NCT00749697
Unknown
Not Applicable
Investigating Absorbed Radiation Dose Delivered to Differentiated Thyroid Cancer Metastases Following Administration of Fixed Activity of Radioactive Iodine
Royal Marsden NHS Foundation Trust1 site in 1 country10 target enrollmentStarted: May 2008Last updated:
Overview
- Phase
- Not Applicable
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- The primary outcome measure is to correlate the predicted dose from the tracer study with the actual absorbed dose measure on the therapeutic scan
Overview
Brief Summary
The main purpose of the study is to establish a relationship between the administered activity of the radioiodine and absorbed dose in the tumor sites.
Detailed Description
Study Design - the assessment of patients with multiple tumour sites with metastatic thyroid cancer to correlate the administered activity to absorbed dose. Patients will receive the standard therapy dose of 5.5 GBq as per the hospital policy and there will be no change for the protocol purpose.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age above 18
- •histological confirmation of the differentiated thyroid carcinoma available
- •WHO performance score 0-2
- •metastatic sites lung and/or bone and/or nodal (radiologically measurable disease \> 1 cm)
- •life expectancy \> 6 months
- •patient has undergone total/near total thyroidectomy
- •no past history of sensitivity/reaction to 1311
Exclusion Criteria
- •non iodine concentrating tumours
- •received chemotherapy or radiotherapy in 6 weeks
- •pregnant or breast feeding patients
- •iodine contrast injection in last 3 months
Outcomes
Primary Outcomes
The primary outcome measure is to correlate the predicted dose from the tracer study with the actual absorbed dose measure on the therapeutic scan
Secondary Outcomes
- The secondary outcomes will be to assess the response at 6 months post therapy in each patient
Investigators
Study Sites (1)
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