Thyroid CancerDOSIMETANCT01403324
Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer
A study testing TSH stimulation in people with Thyroid Cancer and Metastases, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Metastases
- What is being tested?
- TSH stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Cancer, Metastases
- Being tested
- TSH stimulation
- Keywords
- metastatic or locally advanced differentiated thyroid cancer, planned for a therapeutic activity of 131I after thyroid hormone withdrawal
- Medical subject headings
- Thyroid Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSH stimulationDrug
rh TSH stimulation followed by thyroid hormon withdrawal
| Study group | Role | What they receive |
|---|---|---|
| TSH stimulation | Other | rh TSH stimulation followed by thyroid hormon withdrawal Receives: Drug: TSH stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 to 96 hours
Secondary outcomes (2)
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.
Measured: 96 hours
Radiation exposure of the blood
The radiation exposure of the blood, calculated from blood samples and whole body radioactivity measurements
Measured: 4 to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie LEBOULLEUX, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403324
- Sponsor's protocol ID
- DOSIMETA IGR2010/1645
- Acronym
- DOSIMETA
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2011
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01403324
- Acronym / sponsor ID
- DOSIMETA / DOSIMETA IGR2010/1645
- Conditions
- Thyroid Cancer, Metastases
- Keywords
- metastatic or locally advanced differentiated thyroid cancer, planned for a therapeutic activity of 131I after thyroid hormone withdrawal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSH stimulation | Other | Drug: TSH stimulationrh TSH stimulation followed by thyroid hormon withdrawal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSH stimulationrh TSH stimulation followed by thyroid hormon withdrawal | Drug | TSH stimulation |
Primary outcome
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.
2 secondary outcomes
The activity of 131I that should be administered according to each TSH stimulation method
Time frame: 96 hours
Radiation exposure of the blood
Time frame: 4 to 96 hours
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
Related trials for Thyroid Cancer
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie LEBOULLEUX, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TSH stimulation in people with Thyroid Cancer and Metastases, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 124 I uptake after TSH stimulation (time frame: 4 to 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.