Back to resultsRadioiodine Dosimetry Protocol for Thyroid Cancer Metastases
Primary Purpose
Thyroid Carcinoma, Metastatic Sites Lung Bone Nodal
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
SPECT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Carcinoma focused on measuring radioiodine, differentiated thyroid cancers, dosimetry, metastases
Eligibility 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
Sites / Locations
- Royal Marsden NHS Foundation TrustRecruiting
Outcomes
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
Full Information
NCT ID
NCT00749697
First Posted
September 5, 2008
Last Updated
September 8, 2008
Sponsor
Royal Marsden NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT00749697
Brief Title
Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases
Official Title
Investigating Absorbed Radiation Dose Delivered to Differentiated Thyroid Cancer Metastases Following Administration of Fixed Activity of Radioactive Iodine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Marsden NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma, Metastatic Sites Lung Bone Nodal
Keywords
radioiodine, differentiated thyroid cancers, dosimetry, metastases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
SPECT scan
Intervention Description
SPECT scan measures the amount of radio activity that is remaining in patients' body after the consumption of radio iodine for therapeutic purpose
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The secondary outcomes will be to assess the response at 6 months post therapy in each patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Kate Newbold
Phone
020 86613638
Email
kate.newbold@rmh.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Prasad Dandekar
Phone
020 8661 3454
Email
prasad.dandekar@rmh.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Kate Newbold
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Marsden NHS Foundation Trust
City
London
State/Province
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Kate Newbold
Phone
0208661 3638
Email
kate.newbold@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Dr Prasad Dandekar
Phone
020 86613454
Email
prasad.dandekar@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Dr Kate Newbold
12. IPD Sharing Statement
Learn more about this trial
Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases
We'll reach out to this number within 24 hrs