Back to resultsLesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma
Primary Purpose
Thyroid Cancer
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
131 I-iodine (131-I), 124 I-iodine (124-I)
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Cancer focused on measuring 124-IODINE, I-131 METAIODOBENZ SULF (MIBG), Thyroid, Parathyroid
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
131 I-iodine (131-I), 124 I-iodine (124-I)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To determine the diagnostic sensitivity of the 124-Iodine whole body scan based on the 131-Iodine post-therapy scan (the "gold-standard").
Full Information
NCT ID
NCT00673010
First Posted
May 6, 2008
Last Updated
September 27, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00673010
Brief Title
Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma
Official Title
Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
124-IODINE, I-131 METAIODOBENZ SULF (MIBG), Thyroid, Parathyroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
131 I-iodine (131-I), 124 I-iodine (124-I)
Intervention Type
Radiation
Intervention Name(s)
131 I-iodine (131-I), 124 I-iodine (124-I)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravinder Grewal, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma
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