A Retrospective, Non-interventional Study of Patients With T4 Tumours Comparing the Thyroid Remnant Ablation Success Following Thyrogen and 131I Administration Versus Thyroid Hormone Withdrawal and 131I Administration
Historical records from patients who meet all of the following criteria will be eligible
for inclusion in this retrospective evaluation:
1. Male or female patients living or deceased, aged 18 years or older at the time of
first ablation for thyroid cancer.
2. Diagnosed with a well-differentiated T4 tumour (defined as a primary tumour of any
size that extends beyond the thyroid capsule [this may be referred to as TNM
classification T4, N0-1, M0-1]). This excludes unusual histological types such as
oncocytic (Hurthle cell carcinoma), tall cell, sclerosing or cribriform thyroid
3. Undergone a near-total or total thyroidectomy on or after 01 January 2000
4. Undergone first ablation of thyroid remnants with high activity 131I (≥28 mCi or ≥
5. Undergone first 131I ablation for the T4 tumour using either Thyrogen (0.9 mg IM on 2
consecutive days) or THW stimulation. This excludes use of non-standard Thyrogen
regimens (i.e., had a regimen of Thyrogen other than the standard 0.9 mg IM on 2
consecutive days or received Thyrogen in combination with THW).
6. Historical records are available confirming ablation results by:
- DxWBS using small activity (≥2 mCi or 74 MBq) of iodine 131I (or 123I) performed
at least 6 months after administration of the first ablation activity of 131I
- Stimulated Tg measured at least 6 months after administration of the first
ablation activity of 131I.
Historical records from patients who meet any of the following criteria will be excluded
from this retrospective evaluation:
1. Received propylthiouracil, methimazole, vitamins or supplements containing kelp or
iodine (taking a multivitamin that does not contain iodine or kelp is acceptable),
medications that significantly affect iodine handling such as high dose
corticosteroids, high dose diuretics, or lithium in the 45 days before administration
of first ablative activity of 131I.
2. Received any iodine-containing contrast agents within 3 months prior to first
ablative activity of 131I administered.
3. Used amiodarone within the 2 years prior to first ablative activity of 131I