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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00749697
Other study ID # CCR3047
Secondary ID
Status Recruiting
Phase N/A
First received September 5, 2008
Last updated September 8, 2008
Start date May 2008
Est. completion date July 2010

Study information

Verified date September 2008
Source Royal Marsden NHS Foundation Trust
Contact Dr Kate Newbold
Phone 020 86613638
Email kate.newbold@rmh.nhs.uk
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date July 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Other:
SPECT scan
SPECT scan measures the amount of radio activity that is remaining in patients' body after the consumption of radio iodine for therapeutic purpose

Locations

Country Name City State
United Kingdom Royal Marsden NHS Foundation Trust London Sutton

Sponsors (1)

Lead Sponsor Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The secondary outcomes will be to assess the response at 6 months post therapy in each patient
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