NEWS HIGHLIGHTS
Clinical Trials Related to Iodide I-123
Preventing Lack of Iodine During Pregnancy [Recruiting]
The purpose of this study is to evaluate the efficacy of potassium iodide during pregnancy on
neuro-cognitive development of children followed up until two years.
Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development [Recruiting]
Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine
deficiency on neuromotor development are well established: randomized controlled trials of
iodine supplements given to iodine deficient mothers before pregnancy or during early
pregnancy improve motor and cognitive performance of their offspring. However, the potential
adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear.
Inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in
iodine deficiency.
Objective: To determine whether the daily oral administration of 200 µg iodine to pregnant
women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid
function, pregnancy outcome, birth weight, infant growth and cognitive performance.
Study design: Double-blind randomized controlled multicentre trial. Study population:
Pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be
recruited at two research sites, namely St. Martha's hospital in Bangalore, India and
Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. At each site, 400 women will be
recruited.
Intervention: Half of the women will be randomized to iodine treatment (200 µg per day) and
the other half to placebo throughout pregnancy.
Main study parameters/endpoints: Differences between group means in indicators of thyroid
function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor
development.
A Study Of Pharmacokinetics, Whole Body And Organ Dosimetry, And Biodistribution Of Fission-Derived Iodine I 131 Tositumomab (BEXXAR®) For Patients With Previously Untreated Or Relapsed Follicular Or Transformed Non-Hodgkin's Lymphoma [Recruiting]
Patients will receive a standard 5 mCi dosimetric dose of fission-derived Iodine I 131
Tositumomab. Pharmacokinetic data for the primary endpoint analysis will be derived from
testing done on blood samples drawn at 12 timepoints over the first 7 days following
administration of the dosimetric dose. Whole body gamma camera images will be obtained on
six days following the dosimetric dose. Organ and tumor dosimetry data will be generated
from gamma camera counts of specific organs and tumor. All scans will be examined by an
independent review panel to evaluate biodistribution of the radionuclide.
Using the dosimetric data from three of the six imaging time points and the patient's
weight, a patient-specific activity (mCi) of Iodine-131 will be calculated to deliver the
desired total body dose of radiation (75 cGy). Patients will receive an infusion of
unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient specific
dose of tellurium-derived Iodine I 131 Tositumomab (35 mg) to deliver a total body dose
(TBD) of 75 cGy. Patients will be followed closely obtaining safety information during the
post-treatment period, and for response and safety at 3,6,and 12 months during the first
year, annually thereafter up to five years, and annually for additional safety and outcomes
information up to 10 years.
Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma [Recruiting]
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.
A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years [Not yet recruiting]
The purpose of this trial is to determine whether iodide supplementation of neonates born
under 31 weeks gestation improves neurodevelopment measured at two years of age.
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