Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma
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.
|Thyroid Cancer||Radiation: 131 I-iodine (131-I), 124 I-iodine (124-I)||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma|
- 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 ]
- 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 ]
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
131 I-iodine (131-I), 124 I-iodine (124-I)
Radiation: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673010
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Ravinder Grewal, MD||Memorial Sloan Kettering Cancer Center|