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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

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE April 21, 2015
Results First Posted Date  ICMJE November 2, 2018
Last Update Posted Date November 2, 2018
Study Start Date  ICMJE March 2001
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2018)
Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity [ Time Frame: 21 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Increase in FDG PET SUV after rTSH will be more specific for metastases than for nonneoplastic processes (e.g., infection and muscle contraction).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
Official Title  ICMJE Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-differentiated Epithelial Thyroid Cancer
Brief 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Thyroid Cancer
Intervention  ICMJE Drug: Euthyroid Group
Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.
Other Name: Recombinant Human TSH (rhTSH)
Study Arms  ICMJE
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2018)
63
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
70
Actual Study Completion Date  ICMJE September 2003
Actual Primary Completion Date September 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00181168
Other Study ID Numbers  ICMJE THYR01105ORP
JHM IRB #1 ( Other Identifier: Johns Hopkins University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • Gustave Roussy, Cancer Campus, Grand Paris
  • M.D. Anderson Cancer Center
  • Genzyme, a Sanofi Company
Investigators  ICMJE
Principal Investigator: Paul W Ladenson, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date October 2018

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