Comparison of Dosimetry After rhTSH or Withdrawal of Thyr... | NCT01403324

Studies
Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer

NCT01403324

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Terminated

Last Update Posted

Jul 13, 2016Estimated

Enrollment

4Actual

Phase

Not Applicable

Conditions

Thyroid Cancer
Metastases

Interventions

TSH stimulation

Countries

France

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment difficulties

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Jul 26, 2011

First Submission Date that Met QC Criteria

Jul 26, 2011

First Posted Date

Jul 27, 2011Estimated

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

Jul 12, 2016

Last Update Posted Date

Jul 13, 2016Estimated

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

Metastases of thyroid cancer with iodine uptake are treated with repeated activity of I-131 administered after thyroid hormone withdrawal. The goal of thyroid hormone withdrawal is to treat patients with elevated thyrotropin stimulated hormone (TSH), a hormone secreted by the pituitary, a gland just located under the brain. Another way to obtain elevated TSH levels is to perform intramuscular injection of recombinant human TSH, a hormone produced pharmaceutically. The goal of this study is to know whether the radioiodine uptake by the metastases is similar after rhTSH administration or after thyroid hormone withdrawal.

Detailed Description

Patients will undergo a rhTSH stimulation, staying on thyroid hormone treatment. Following 2 administration of rhTSH an injection of I-124 will be performed. Positron emission tomography with computed tomography scans (PET/CT), blood tests, and measurements of whole body radioactivity will occurred during the 4 to 96 hours following I-124 administration in order to perform dosimetry (i.e.) to estimate the radiation dose delivered to the metastases. After 4 weeks under thyroid hormones patients will undergo thyroid hormone withdrawal and a new administration of I-124 will be performed. The same dosimetry study will be realized with PET/CT, blood tests, and measurements of whole body radioactivity. A therapeutic activity of I-131will then be administered followed by whole body scan realized 24 to 72 hours after the administration of I-131. Dosimetry studies will be compared in order to determine whether rhTSH stimulation can replace thyroid hormone withdrawal for the treatment of distant metastases.

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

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TSH stimulation	Other	rh TSH stimulation followed by thyroid hormon withdrawal	Drug: TSH stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TSH stimulation	Drug	rh TSH stimulation followed by thyroid hormon withdrawal	TSH stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the 124 I uptake after TSH stimulation	For each patient, the 124 I uptake after TSH stimulation (a marker of radiation absorbed dose) will be compared to the uptake after thyroid withdrawal in all lesions (up to 16 lesions per patient maximum). A decrease in the residence time of more than 2.5 fold in 25% or more of the lesions is considered unacceptable.	4 to 96 hours

Secondary Outcomes

Measure	Description	Time Frame
The activity of 131I that should be administered according to each TSH stimulation method	To determine the activity of 131I that should be administered following rhTSH to deliver a radiation absorbed dose similar to that delivered under hypothyroid conditions. A calculated activity above 250mCi is considered unacceptable.	96 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with thyroid cancer and known measurable (>1cm) distant metastases demonstrating radioiodine uptake on a previous whole body scan
Patients planned for a therapeutic activity of 131I after thyroid hormone withdrawal
Age >18 years
Previous treatment with radioiodine more than 6 months before inclusion.
Serum TSH level <0.5 mU/L
Normal renal function with a creatinine clearance estimation using the Cockcroft-Gault formula > 60 ml/ml
Effective means of contraception for female patient, at risk of pregnancy
Written informed consent

Exclusion Criteria:

Patients whose majority of tumoral lesions disclose FDG uptake without radioactive iodine uptake
Iodine excess (< 50 μg/dl)
Large or diffuse bone or brain metastases
Patients with multiple small tumor foci less than 1 cm in diameter, such as miliary spread to the lungs
Patients already included in a therapeutic trial with an experimental medicine
Pregnancy and breast feeding patients
Subject with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Treatment with antivitamin k

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

Name	Affiliation	Role
Sophie LEBOULLEUX, MD	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy		Villejuif		94805	France

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

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Browse Branches

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