Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases | NCT00749697

Studies
Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases

NCT00749697

Sponsor

Royal Marsden NHS Foundation Trust

Status

Unknown status

Last Update Posted

Sep 9, 2008Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Thyroid Carcinoma
Metastatic Sites Lung Bone Nodal

Interventions

SPECT scan

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jan 2010Estimated

Completion Date

Jul 2010Estimated

First Submitted Date

Sep 5, 2008

First Submission Date that Met QC Criteria

Sep 8, 2008

First Posted Date

Sep 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2008

Last Update Posted Date

Sep 9, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPECT scan	Other	SPECT scan measures the amount of radio activity that is remaining in patients' body after the consumption of radio iodine for therapeutic purpose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr Kate Newbold	Contact	020 86613638		kate.newbold@rmh.nhs.uk
Dr Prasad Dandekar	Contact	020 8661 3454		prasad.dandekar@rmh.nhs.uk

Overall Officials

Name	Affiliation	Role
Dr Kate Newbold	Royal Marsden NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Marsden NHS Foundation Trust	Recruiting	London	Sutton	SM2 5PT	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided