Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer (DOSIMETA)

July 12, 2016 updated by: Gustave Roussy, Cancer Campus, Grand Paris

Comparison of Dosimetry Following Preparation With Either rhTSH or After Withdrawal of Thyroid Hormone Suppression Therapy in Patients With Metastatic or Locally Advanced Differentiated Thyroid Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

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

  • France
      • Villejuif, France, 94805
        • Institut Gustave Roussy

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:

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

Exclusion Criteria:

  1. Patients whose majority of tumoral lesions disclose FDG uptake without radioactive iodine uptake
  2. Iodine excess (< 50 μg/dl)
  3. Large or diffuse bone or brain metastases
  4. Patients with multiple small tumor foci less than 1 cm in diameter, such as miliary spread to the lungs
  5. Patients already included in a therapeutic trial with an experimental medicine
  6. Pregnancy and breast feeding patients
  7. 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
  8. Treatment with antivitamin k

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

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: TSH stimulation
rh TSH stimulation followed by thyroid hormon withdrawal
Drug: TSH stimulation
rh TSH stimulation followed by thyroid hormon withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the 124 I uptake after TSH stimulation
Time Frame: 4 to 96 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The activity of 131I that should be administered according to each TSH stimulation method
Time Frame: 96 hours
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
Radiation exposure of the blood
Time Frame: 4 to 96 hours
The radiation exposure of the blood, calculated from blood samples and whole body radioactivity measurements
4 to 96 hours

Collaborators and Investigators

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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

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

September 1, 2011

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (ESTIMATE)

July 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOSIMETA IGR2010/1645

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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