Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases

Thyroid Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00749697
• Other study ID #: CCR3047
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2008
• Last updated: September 8, 2008
• Start date: May 2008
• Est. completion date: July 2010

Study information

• Verified date: September 2008
• Source: Royal Marsden NHS Foundation Trust
• Contact: Dr Kate Newbold
• Phone: 020 86613638
• Email: kate.newbold[@]rmh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Metastatic Sites Lung Bone Nodal
• Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	London	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The secondary outcomes will be to assess the response at 6 months post therapy in each patient