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Completed

NCT Number: NCT00181168

Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute Gustave Roussy, Paris, France

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About this study

PET/CT was performed before (basal PET) and 24 - 48 h after rhTSH administration (rhTSH-PET) in 63 patients (52 papillary and 11 follicular thyroid cancers). Images were blindly analyzed by two readers. The proposed treatment plan was prospectively assessed before basal PET, after basal PET, and again after rhTSH-PET.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults (aged ≥ 18 years) with history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular or Hurthle cell), for which total or near total thyroidectomy plus postoperative radioiodine remnant ablation with 131-I has either been performed or found to be unnecessary by radioiodine imaging after TSH stimulation.
  • Serum thyroglobulin (Tg) concentration ≥ 10 ng/mL (in the absence of interfering Tg autoantibodies).
  • No findings of a "qualifying" radioiodine whole body scan that are sufficient to localize the disease suspected on the basis of the serum Tg.
  • Inconclusive disease localization despite clinical assessment, cervical sonography, CT or magnetic resonance (MR) of the chest, and when appropriate other imaging and biopsy procedures. Patients must have no more than three foci of known or suspected extra-cervical metastasis.
  • Must be in stable medical condition.
  • Must be able to fully understand the protocol and be compliant with instructions.

Exclusion criteria

  • Diabetes mellitus, due to interference with fluorodeoxyglucose (FDG) PET scanning.
  • Claustrophobia, inability to lay supine, or other factors preventing cooperation with scanning procedures.
  • Withdrawal of thyroid hormone or rTSH administration within the preceding month.
  • Presence of circulating Tg autoantibodies interfering with serum Tg measurement.
  • Women who are pregnant or breastfeeding

Treatment and study plan

Euthyroid Group

Drug

Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.

Other names: Recombinant Human TSH (rhTSH)

Primary outcomes

  1. PET-CT Fusion Scanning Sensitivity

    Time frame: 21 Days

    PET/CT was performed before (basal PET) and 24-48 h after rhTSH administration (rhTSH-PET) in 63 patients (52 papillary and 11 follicular thyroid cancers). Images were blindly analyzed by two readers. The proposed treatment plan was prospectively assessed before basal PET, after basal PET, and again after rhTSH-PET.

Secondary outcomes

  1. Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity

    Time frame: 21 Days

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Genzyme, a Sanofi Company
  • Gustave Roussy, Cancer Campus, Grand Paris
  • M.D. Anderson Cancer Center

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Sep 16, 2005
Registry last updated
Nov 2, 2018

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.

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