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Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
Information provided by:
Royal Marsden NHS Foundation Trust Identifier:
First received: September 5, 2008
Last updated: September 8, 2008
Last verified: September 2008
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 Intervention
Thyroid Carcinoma Metastatic Sites Lung Bone Nodal Other: SPECT scan

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Royal Marsden NHS Foundation Trust:

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

Estimated Enrollment: 10
Study Start Date: May 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00749697

Contact: Dr Kate Newbold 020 86613638
Contact: Dr Prasad Dandekar 020 8661 3454

United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
London, Sutton, United Kingdom, SM2 5PT
Contact: Dr Kate Newbold    0208661 3638   
Contact: Dr Prasad Dandekar    020 86613454   
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 Identifier: NCT00749697     History of Changes
Other Study ID Numbers: CCR3047
Study First Received: September 5, 2008
Last Updated: September 8, 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 processed this record on September 21, 2017