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Trial record 1 of 1 for:    NCT00749697
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Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases

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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
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust

Study Description
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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 Phase
Thyroid Carcinoma Metastatic Sites Lung Bone Nodal Other: SPECT scan Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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

Arms and Interventions
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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
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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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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


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

Locations
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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
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Principal Investigator: Dr Kate Newbold Royal Marsden NHS Foundation Trust
More Information
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Responsible Party: Dr Kate Newbold, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00749697    
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:
radioiodine
differentiated thyroid cancers
dosimetry
metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Thyroid Neoplasms
Thyroid Diseases
Neoplastic Processes
Neoplasms
 Pathologic Processes
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms