Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer
The Effects of Lithium Carbonate on Low Dose Radioiodine Ablation in Early Thyroid Cancer Treatment
2 other identifiers
interventional
34
1 country
1
Brief Summary
This study will examine the safety and effectiveness of using lithium, which has been used to enhance the effectiveness of high-dose 131I, with a single low dose (30 mCi) of 131I for thyroid ablation in patients with recently diagnosed papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid. Participants are randomly assigned to receive lithium capsules or placebo (look-alike capsules with no active ingredient). They follow a low-iodine diet for 2 weeks before starting treatment and are then admitted to the NIH Clinical Center for study and treatment for 11 days, during which they remain on the low-iodine diet. Blood samples are collected almost every day to analyze thyroid hormones, kidney and liver function, lithium concentrations and other tests.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
December 27, 2012
CompletedFebruary 4, 2013
January 1, 2013
6.1 years
November 9, 2005
November 20, 2012
January 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Rate of Successful Thyroid Ablation as Defined by Negative Recombinant Human Thyrotropin (rhTSH) Stimulated Radioiodine Whole Body Scan (RAI WBS) at 1 Year.
1 year
Study Arms (2)
Lithium Carbonate
EXPERIMENTALPatients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
Placebo
PLACEBO COMPARATORPatients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
Interventions
Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
Eligibility Criteria
You may qualify if:
- Patients older than 16 years with well-differentiated papillary or follicular thyroid cancer stage I or II, according to the NTCTCS classification at time of surgery
- Patients younger than 45 years with any size of primary papillary or follicular tumor
- Patients older than 45 years with:
- primary papillary tumor less than 4 cm or
- primary follicular tumor less than 1 cm
You may not qualify if:
- Patients with postsurgical thyroid remnant more than 5 g
- Patients with distant metastases
- Patients above 45 years of age having:
- known cervical lymph nodes metastases
- microscopic multifocal follicular cancer
- microscopic extraglandular invasion of follicular cancer
- gross extraglandular invasion of papillary or follicular cancer
- Patients with confirmed histological subtypes of well-differentiated thyroid cancer such as Hurtle cell carcinoma, insular and tall cell variants of papillary cancer.
- Pregnant or lactating women
- Patients with renal impairment defined as repeat serum creatinine concentrations above 1.5 mg/dl on thyroid hormone
- Patients on chronic lithium therapy for psychiatric illness
- Patients with current unstable cardiovascular conditions
- Patients with severe chronic medical conditions (liver failure, severe debilitation, dehydration, sodium depletion, any other cancer requiring therapy, etc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Sherman SI. Thyroid carcinoma. Lancet. 2003 Feb 8;361(9356):501-11. doi: 10.1016/s0140-6736(03)12488-9.
PMID: 12583960BACKGROUNDMazzaferri EL. An overview of the management of papillary and follicular thyroid carcinoma. Thyroid. 1999 May;9(5):421-7. doi: 10.1089/thy.1999.9.421.
PMID: 10365671BACKGROUNDMazzaferri EL, Jhiang SM. Long-term impact of initial surgical and medical therapy on papillary and follicular thyroid cancer. Am J Med. 1994 Nov;97(5):418-28. doi: 10.1016/0002-9343(94)90321-2.
PMID: 7977430BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Monica Skarulis
- Organization
- NIDDK, NIH
Study Officials
- PRINCIPAL INVESTIGATOR
Monica C Skarulis, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PI
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 9, 2005
Study Start
November 1, 2005
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 4, 2013
Results First Posted
December 27, 2012
Record last verified: 2013-01