Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749697
Recruitment Status : Unknown
Verified September 2008 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : September 9, 2008
Last Update Posted : September 9, 2008
Information provided by:
Royal Marsden NHS Foundation Trust

September 5, 2008
September 9, 2008
September 9, 2008
May 2008
January 2010   (Final data collection date for primary outcome measure)
The primary outcome measure is to correlate the predicted dose from the tracer study with the actual absorbed dose measure on the therapeutic scan
Same as current
No Changes Posted
The secondary outcomes will be to assess the response at 6 months post therapy in each patient
Same as current
Not Provided
Not Provided
Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases
Investigating Absorbed Radiation Dose Delivered to Differentiated Thyroid Cancer Metastases Following Administration of Fixed Activity of Radioactive Iodine
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.
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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Thyroid Carcinoma
  • Metastatic Sites Lung Bone Nodal
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
July 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
Dr Kate Newbold, Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Not Provided
Principal Investigator: Dr Kate Newbold Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP