Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases

September 8, 2008 updated by: Royal Marsden NHS Foundation Trust

Investigating Absorbed Radiation Dose Delivered to Differentiated Thyroid Cancer Metastases Following Administration of Fixed Activity of Radioactive Iodine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Sutton
      • London, Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden NHS Foundation Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr Kate Newbold

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
The secondary outcomes will be to assess the response at 6 months post therapy in each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Dr Kate Newbold, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 8, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

September 9, 2008

Last Update Submitted That Met QC Criteria

September 8, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR3047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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