Skip to main content
OpenTrials
Completed

NCT Number: NCT01736163

A Retrospective Observational Study Comparing Two Different Treatment Options in Thyroid Cancer Patients With T4 Tumours

The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour based on historical diagnostic whole body scan (DxWBS) records.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanover University School of Medicine, Hanover, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Historical records from patients who meet all of the following criteria will be eligible for inclusion in this retrospective evaluation:

  • Male or female patients living or deceased, aged 18 years or older at the time of first ablation for thyroid cancer.
  • 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 cancers.
  • Undergone a near-total or total thyroidectomy on or after 01 January 2000
  • Undergone first ablation of thyroid remnants with high activity 131I (≥28 mCi or ≥ 1.036 GBq).
  • 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).
  • 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 and/or
  • Stimulated Tg measured at least 6 months after administration of the first ablation activity of 131I.

Exclusion criteria

Historical records from patients who meet any of the following criteria will be excluded from this retrospective evaluation:

  • 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.
  • Received any iodine-containing contrast agents within 3 months prior to first ablative activity of 131I administered.
  • Used amiodarone within the 2 years prior to first ablative activity of 131I administered.

Treatment and study plan

Thyrogen

Drug

0.9 mg IM, administrated for 2 consecutive days

131I

Drug

28 mCi or ≥ 1.036 GBq.

Thyroid hormone withdrawal

Other

Stop taking hormone therapy

Primary outcomes

  1. First ablation success rate by Diagnostic Whole Body Scan (DxWBS)

    Time frame: at least 6 months after administration of first ablation activity of 131I

Secondary outcomes

  1. First ablation success rate based on stimulated Thyroglobulin (Tg) levels

    Time frame: at least 6 months after administration of first ablation activity of 131I

  2. First ablation success rate based on historical records

    Time frame: at least 6 months after administration of first ablation activity of 131I

  3. Number of adverse events of Thyrogen and 131I arm and THW and 131I arm

    Time frame: Within 30 days of treatment.

    Exploratory safety assessment in patients with T4 tumour for first ablation of thyroid remnants based on historical records.

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 29, 2012
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.