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Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT00181168
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
Gustave Roussy, Cancer Campus, Grand Paris
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Johns Hopkins University

September 12, 2005
September 16, 2005
April 21, 2015
November 2, 2018
November 2, 2018
March 2001
September 2003   (Final data collection date for primary outcome measure)
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.
PET-CT fusion scanning after rTSH will be more sensitive to detect disease sites than scana without rTSH; this information will significantly alter the therapeutic approach in some patients.
Complete list of historical versions of study NCT00181168 on ClinicalTrials.gov Archive Site
Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity [ Time Frame: 21 Days ]
Increase in FDG PET SUV after rTSH will be more specific for metastases than for nonneoplastic processes (e.g., infection and muscle contraction).
Not Provided
Not Provided
 
Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-differentiated Epithelial 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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Thyroid Cancer
Drug: Euthyroid Group
Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.
Other Name: Recombinant Human TSH (rhTSH)
  • Experimental: Euthyroid Group
    Euthyroid Group: Subjects received rhTSH to prepare for radioiodine therapy.
    Intervention: Drug: Euthyroid Group
  • No Intervention: Hypothyroid Group
    Hypothyroid Group: Thyroid hormone treatment was withheld before radioiodine therapy.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
70
September 2003
September 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France,   United States
 
 
NCT00181168
THYR01105ORP
JHM IRB #1 ( Other Identifier: Johns Hopkins University )
No
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
  • Gustave Roussy, Cancer Campus, Grand Paris
  • M.D. Anderson Cancer Center
  • Genzyme, a Sanofi Company
Principal Investigator: Paul W Ladenson, MD Johns Hopkins University
Johns Hopkins University
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP