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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.
ClinicalTrials.gov 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:

Study Description
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.

Condition or disease Intervention/treatment
Thyroid Carcinoma Metastatic Sites Lung Bone Nodal Other: SPECT scan

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigating Absorbed Radiation Dose Delivered to Differentiated Thyroid Cancer Metastases Following Administration of Fixed Activity of Radioactive Iodine
Study Start Date : May 2008
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The secondary outcomes will be to assess the response at 6 months post therapy in each patient

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749697

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
Royal Marsden NHS Foundation Trust Recruiting
London, Sutton, United Kingdom, SM2 5PT
Contact: Dr Kate Newbold    0208661 3638    kate.newbold@rmh.nhs.uk   
Contact: Dr Prasad Dandekar    020 86613454    prasad.dandekar@rmh.nhs.uk   
Principal Investigator: Dr Kate Newbold         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Principal Investigator: Dr Kate Newbold Royal Marsden NHS Foundation Trust
More Information

Responsible Party: Dr Kate Newbold, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00749697     History of Changes
Other Study ID Numbers: CCR3047
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: September 9, 2008
Last Verified: September 2008

Keywords provided by Royal Marsden NHS Foundation Trust:
differentiated thyroid cancers

Additional relevant MeSH terms:
Neoplasm Metastasis
Thyroid Diseases
Thyroid Neoplasms
Neoplastic Processes
Pathologic Processes
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms