Skip to content

Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer

L-T3 Preparation for I131 Whole Body Scintigraphy: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00223158
Enrollment
70
Registered
2005-09-22
Start date
2003-09-30
Completion date
2005-05-31
Last updated
2014-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer

Keywords

Thyroid cancer, Hypothyroidism, Whole Body Scintigraphy, Liothyronine, TSH elevation

Brief summary

To compare the hypothyroid state in patients with thyroid cancer prepared either by placebo or L-T3 following L-T4 withdrawal in preparation for whole body scintigraphy. To evaluate the time needed for TSH elevation (\> 30 mUI/L) on placebo vs. L-T3.

Detailed description

Patients with well differentiated thyroid cancer (DTC) need whole-body scintigraphy (WBS) and thyroglobulin (Tg) measurement in order to detect recurrence. Classically, withdrawal from levothyroxine (L-T4) during 4-6 weeks is needed for TSH elevation (\> 30mUI/L), to allow iodine uptake and Tg production. As a result, patients become hypothyroid with impaired quality of life and a potential for tumour flare-up. Recombinant hTSH before WBS prevents hypothyroidism but is not yet approved for radioiodine treatment and is an expensive therapy. L-T3 substitution during the first 2-3 weeks of withdrawal is an alternative used empirically to prepare patients; however, no data exists to prove its benefit upon reducing hypothyroidism. Objectives: 1) To compare the hypothyroid state in patients prepared either by placebo or L-T3 following L-T4 withdrawal. 2) To evaluate the time needed for TSH elevation (\> 30 mUI/L) on placebo vs. L-T3. Method: At the time of L-T4 withdrawal or after thyroidectomy, patients with DTC awaiting WBS or radioiodine treatment were randomized in two groups (double-blind): L-T3 (50 mg qd) or an identical placebo for 3 weeks, after which treatment was stopped for 2 weeks. A validated questionnaire of signs and symptoms of hypothyroidism (Billewicz's scale) was administered every 2 weeks until the WBS. TSH, fT4 and fT3 were measured weekly.

Interventions

Sponsors

Theramed co.
CollaboratorUNKNOWN
Patrice Perron
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with well-differentiated thyroid cancer, with total thyroidectomy * 18 y.o. or older

Exclusion criteria

* Use of rhTSH for Whole Body Scintigraphy preparation * Non stable cardiac arrythmias * Any condition impairing TSH elevation(glucocorticoid use, hypopituitarism) * Allergy to Liothyronine * Inability to give a consent

Design outcomes

Primary

MeasureTime frame
Evaluation of the hypothyroid status by the Billewicz questionnaire.

Secondary

MeasureTime frame
The time to reach an acceptable TSH elevation.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026