Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00749697
First received: September 5, 2008
Last updated: September 8, 2008
Last verified: September 2008

September 5, 2008
September 8, 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
Complete list of historical versions of study NCT00749697 on ClinicalTrials.gov Archive Site
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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
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
Both
18 Years and older
No
Contact: Dr Kate Newbold 020 86613638 kate.newbold@rmh.nhs.uk
Contact: Dr Prasad Dandekar 020 8661 3454 prasad.dandekar@rmh.nhs.uk
United Kingdom
 
NCT00749697
CCR3047
No
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