Follow-up of Thyroid Cancer Patients from Study THYR-008-00 Who Received Thyroid Remnant Ablation Using Either the Hypothyroid or the Thyrogen Method - ND

GENZYME0 个研究点目标入组 61 人开始时间: 2006年6月23日最近更新: 2012年3月19日

适应症

试验速览

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•1. Committed to follow the protocol requirements, as evidenced by providing written informed consent before any study-related procedures are performed and within 28 days prior to Day 1; 2. Completed the THYR-008-00 study; 3. A negative serum pregnancy test within 8 days prior to the start of the week during which the patient will receive Thyrogen and radioiodine required for all pre-menopausal women of child bearing potential, with menopause defined as age 50 years with 2 years without a menstrual period .
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Patients who are currently taking amiodarone or other prescribed iodine-containing medication; 2. Patients who received iodine-containing X-ray contrast material within the prior 3 months; 3. Women of child-bearing potential, unless confirmed to have a negative pregnancy test prior to dosing; 4. Women who are pregnant or lactating; 5. Patients who are currently participating in another investigational drug study or who have participated in such a study within 30 days of their enrollment in this study; 6. Patients who are unwilling or unable to complete all the required study procedures per protocol with the exception of patients for whom scanning could pose a medical risk ; 7. The patient who by mistake received only one-half the intended dose of Thyrogen during THYR-008-00 Patient 209 ; 8. The patient in THYR-008-00 who was found to have lung metastases on her post therapy scan Patient 204 ; 9. A concurrent major medical disorder e.g., documented significant cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease, advanced pulmonary disease, or advanced cerebral vascular disorder that may have an impact on the capability of the patient to adequately comply with the requirements of this study.

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