NCT00223158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

April 9, 2014

Status Verified

July 1, 2005

Enrollment Period

1.7 years

First QC Date

September 19, 2005

Last Update Submit

April 8, 2014

Conditions

Thyroid Cancer

Keywords

Thyroid cancerHypothyroidismWhole Body ScintigraphyLiothyronineTSH elevation

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the hypothyroid status by the Billewicz questionnaire.

Secondary Outcomes (1)

  • The time to reach an acceptable TSH elevation.

Interventions

LiothyronineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Thyroid NeoplasmsHypothyroidism

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

ThyroninesThyroid HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroxineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Rébecca Leboeuf, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

  • Marie-France Langlois, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

  • Patrice Perron, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

  • André Carpentier, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

  • Jean Verreault, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

September 1, 2003

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

April 9, 2014

Record last verified: 2005-07

Locations

CA(1)