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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
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749697

Contacts
Contact: Dr Kate Newbold 020 86613638 kate.newbold@rmh.nhs.uk
Contact: Dr Prasad Dandekar 020 8661 3454 prasad.dandekar@rmh.nhs.uk

Locations
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
Investigators
Principal Investigator: Dr Kate Newbold Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Kate Newbold, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00749697     History of Changes
Other Study ID Numbers: CCR3047
Study First Received: September 5, 2008
Last Updated: September 8, 2008
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Carcinoma
Thyroid Neoplasms
Neoplasm Metastasis
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013