Thyroid CancerPhase 1NCT00673010
Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma
A Phase 1 study testing 131 I-iodine (131-I), 124 I-iodine (124-I) in people with Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
One of the most effective treatments for metastases from thyroid cancer is a form of radioactive iodine known as 131-I. For more than 50 years, 131-I has been used to find and destroy thyroid cancer cells that have spread to other parts of the body. In many cases this treatment destroys the metastatic cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- 131 I-iodine (131-I), 124 I-iodine (124-I)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2005to 2 Oct 2025
- Phase
- Phase 1
- 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
- Adult thyroid carcinoma patients who have had a total thyroidectomy, histology confirmed by an MSKCC attending pathologist, and radioiodine remnant ablation.
- Adult thyroid carcinoma patients who have previously demonstrated radioiodine-avid metastases and are about to undergo Thyrogen-assisted dosimetry at MSKCC.
- The patient and physician are planning to administer 131-I for therapy if persistent radioiodine-avid metastases are present.
- Men and women of all races, ethnicities, and religious backgrounds are eligible.
- All subjects must have measurable disease, documented within the previous six months by ultrasonography (US), MRI, or non-contrast CT scanning.
Who cannot join
- Thyroid cancer patients who do not have metastases.
- Thyroid cancer patients who have not demonstrated that their metastases concentrate radioiodine.
- Patients who are under therapy for other active cancers.
- Anaplastic or Medullary thyroid carcinoma.
- Age less than 18 years.
- Patient who have received a therapeutic dose of radioiodine within the preceding nine months will not be eligible.
- Patients who plan to withdraw from thyroid hormone prior to dosimetry.
- Patients who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
One of the most effective treatments for metastases from thyroid cancer is a form of radioactive iodine known as 131-I. For more than 50 years, 131-I has been used to find and destroy thyroid cancer cells that have spread to other parts of the body. In many cases this treatment destroys the metastatic cells. However, in some patients it does not appear to work completely. This study is designed to use a slightly different form of radioactive iodine (called 124-I) which can precisely predict the amount of radiation that each metastatic lesion will receive.
124-I was developed at Memorial Sloan-Kettering in the 1950s and has been used here and at many other medical centers around the world for diagnostic studies. It has been found to be very safe and effective at finding metastatic lesions. The high resolution of newer PET scanners now allows us to carefully determine how much radiation each metastatic lesion will receive. If 124-I can accurately predict which patients will not respond to 131-I treatments we can then avoid exposing those patients to unnecessary radiation. For the rest of the patients we can custom tailor the 131-I dose to destroy the metastatic lesions.
- Conditions
- Thyroid Cancer
- Being tested
- 131 I-iodine (131-I), 124 I-iodine (124-I)
- Keywords
- 124-IODINE, I-131 METAIODOBENZ SULF (MIBG), Thyroid, Parathyroid
- Medical subject headings
- Thyroid Neoplasms, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131 I-iodine (131-I), 124 I-iodine (124-I)Radiation
Those who have demonstrated metastases which concentrate radioiodine will undergo routine testing to determine the MTA for blood and lung tissue. This will be performed with 124-I instead of 131-I. If the diagnostic scans (done with 123-I) show that the metastatic lesions concentrate radioiodine, the patient will be treated with 131-I based on standard of care discussions at a tumor board meeting. One week following the 131-I therapy, a whole body scan will be obtained and compared with the 124-I diagnostic scan. One year later, another extent of disease workup will be performed which will include 124-I dosimetry and scanning.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 131 I-iodine (131-I), 124 I-iodine (124-I) Receives: Radiation: 131 I-iodine (131-I), 124 I-iodine (124-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the relationship between the radiation dose and response to radiation at one year for metastatic lesions arising from differentiated thyroid carcinoma, following a single therapeutic administration of 131-Iodine.
Measured: conclusion of the study
Secondary outcomes (1)
To determine the diagnostic sensitivity of the 124-Iodine whole body scan based on the 131-Iodine post-therapy scan (the "gold-standard").
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study start7 Mar 2005
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
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 Memorial Sloan Kettering Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Responsible party
- Sponsor
- Investigators
- Ravinder Grewal, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673010
- Sponsor's protocol ID
- 04-116
- Status last verified
- Oct 2025
- First submitted
- 6 May 2008
- Last updated
- 9 Oct 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT00673010
- Acronym / sponsor ID
- 04-116
- Conditions
- Thyroid Cancer
- Keywords
- 124-IODINE, I-131 METAIODOBENZ SULF (MIBG), Thyroid, Parathyroid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Study start
- 7 Mar 2005 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 7 May 2008 (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.
One of the most effective treatments for metastases from thyroid cancer is a form of radioactive iodine known as 131-I. For more than 50 years, 131-I has been used to find and destroy thyroid cancer cells that have spread to other parts of the body. In many cases this treatment destroys the metastatic cells. However, in some patients it does not appear to work completely. This study is designed to use a slightly different form of radioactive iodine (called 124-I) which can precisely predict the amount of radiation that each metastatic lesion will receive.
124-I was developed at Memorial Sloan-Kettering in the 1950s and has been used here and at many other medical centers around the world for diagnostic studies. It has been found to be very safe and effective at finding metastatic lesions. The high resolution of newer PET scanners now allows us to carefully determine how much radiation each metastatic lesion will receive. If 124-I can accurately predict which patients will not respond to 131-I treatments we can then avoid exposing those patients to unnecessary radiation. For the rest of the patients we can custom tailor the 131-I dose to destroy the metastatic lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: 131 I-iodine (131-I), 124 I-iodine (124-I)131 I-iodine (131-I), 124 I-iodine (124-I) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult thyroid carcinoma patients who have had a total thyroidectomy, histology confirmed by an MSKCC attending pathologist, and radioiodine remnant ablation.
- Adult thyroid carcinoma patients who have previously demonstrated radioiodine-avid metastases and are about to undergo Thyrogen-assisted dosimetry at MSKCC.
- The patient and physician are planning to administer 131-I for therapy if persistent radioiodine-avid metastases are present.
- Men and women of all races, ethnicities, and religious backgrounds are eligible.
- All subjects must have measurable disease, documented within the previous six months by ultrasonography (US), MRI, or non-contrast CT scanning.
Key exclusion criteria (8 listed)
- Thyroid cancer patients who do not have metastases.
- Thyroid cancer patients who have not demonstrated that their metastases concentrate radioiodine.
- Patients who are under therapy for other active cancers.
- Anaplastic or Medullary thyroid carcinoma.
- Age less than 18 years.
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 |
|---|---|---|
| 131 I-iodine (131-I), 124 I-iodine (124-I)Those who have demonstrated metastases which concentrate radioiodine will undergo routine testing to determine the MTA for blood and lung tissue. This will be performed with 124-I instead of 131-I. If the diagnostic scans (done with 123-I) show that the metastatic lesions concentrate radioiodine, the patient will be treated with 131-I based on standard of care discussions at a tumor board meeting. One week following the 131-I therapy, a whole body scan will be obtained and compared with the 124-I diagnostic scan. One year later, another extent of disease workup will be performed which will include 124-I dosimetry and scanning. | Radiation | 1 |
Primary outcome
To estimate the relationship between the radiation dose and response to radiation at one year for metastatic lesions arising from differentiated thyroid carcinoma, following a single therapeutic administration of 131-Iodine.
Time frame: conclusion of the study
1 secondary outcome
To determine the diagnostic sensitivity of the 124-Iodine whole body scan based on the 131-Iodine post-therapy scan (the "gold-standard").
Time frame: conclusion of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Ravinder Grewal, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 131 I-iodine (131-I), 124 I-iodine (124-I) in people with Thyroid Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 9 Oct 2025. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To estimate the relationship between the radiation dose and response to radiation at one year for metastatic lesions arising from differentiated thyroid carcinoma, following a single therapeutic administration of 131-Iodine. (time frame: conclusion of the study). 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 9 Oct 2025.