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
Recruitment status was Recruiting
Sponsor:
Royal Marsden NHS Foundation Trust
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 5, 2008 | ||||||||
| Last Updated Date | September 8, 2008 | ||||||||
| Start Date ICMJE | May 2008 | ||||||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The primary outcome measure is to correlate the predicted dose from the tracer study with the actual absorbed dose measure on the therapeutic scan | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00749697 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
The secondary outcomes will be to assess the response at 6 months post therapy in each patient | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases | ||||||||
| Official Title ICMJE | Investigating Absorbed Radiation Dose Delivered to Differentiated Thyroid Cancer Metastases Following Administration of Fixed Activity of Radioactive Iodine | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Estimated Completion Date | July 2010 | ||||||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00749697 | ||||||||
| Other Study ID Numbers ICMJE | CCR3047 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr Kate Newbold, Royal Marsden NHS Foundation Trust | ||||||||
| Study Sponsor ICMJE | Royal Marsden NHS Foundation Trust | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Royal Marsden NHS Foundation Trust | ||||||||
| Verification Date | September 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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