CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Euthyroid Groupdrug
Likely dose
rhTSH (specific dose not stated in protocol)AI-extracted
Key inclusion· 7
  • Age ≥18 years
  • History of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hurthle cell) with total or near total thyroidectomy and postoperative radioiodine ablation or imaging showing ablation unnecessary
  • Serum thyroglobulin ≥10 ng/mL without interfering autoantibodies
  • No qualifying radioiodine whole body scan findings sufficient to localize disease despite elevated thyroglobulin
Key exclusion· 5
  • Diabetes mellitus
  • Claustrophobia, inability to lay supine, or other factors preventing cooperation with scanning procedures
  • Thyroid hormone withdrawal or rTSH administration within the preceding month
  • Circulating thyroglobulin autoantibodies interfering with serum thyroglobulin measurement

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00181168
NCT00181168Phase 2Completed

Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-differentiated Epithelial Thyroid Cancer

Johns Hopkins University·interventional·Posted Sep 16, 2005·Updated Nov 2, 2018

In Brief

A Phase 2 clinical trial evaluating Euthyroid Group for Thyroid Cancer. Completed, enrolled 63 participants across 3 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine \[for patients with previously treated well-differentiated thyroid cancer and evidence of residual disease based on serum thyroglobulin (Tg) level\] whether positron emission tomography-computed tomography (PET-CT) fusion scanning performed after recombinant thyroid-stimulating hormone (TSH) (rTSH, thyrotropin alfa for injection) will be more sensitive for the detection of disease sites than PET-CT scanning without rTSH. The study will also determine if this information will significantly alter the therapeutic approach in some patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Cancer
CountriesFrance, United States

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartMar 1, 2001
Primary CompletionSep 1, 2003
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.8 years ago

Interventions

Euthyroid Groupdrug

Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.