Follow-up of Thyroid Cancer Patients from Study THYR-008-00 MedDRA version: 6.1 Level: PT Classification code 10043738
Conditions
Interventions
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Thyrotropin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .9-
Sponsors
GENZYME
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the status of thyroid remnant ablation by using Thyrogen-stimulated radioiodine static neck imaging in patients previously treated in the THYR-008-00 study.;Secondary Objective: To learn if there was recurrence of thyroid cancer in any of the patients previously treated in the THYR-008-00 study. To assess Thyrogen-stimulated serum thyroglobulin Tg measurements in patients previously treated in the THYR-008-00 study. To assess safety information on repeat exposure to Thyrogen in patients previously treated in the THYR-008-00 study;Primary end point(s): To confirm the status of thyroid remnant ablation by using Thyrogen-stimulated radioiodine static neck imaging in patients previously treated in the THYR-008-00 study | — |
Countries
Italy
Outcome results
None listed