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Trial record 1 of 1 for:    NCT00181168
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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: Euthyroid Group Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-differentiated Epithelial Thyroid Cancer
Study Start Date : March 2001
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arms and Interventions
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Arm Intervention/treatment
Experimental: Euthyroid Group
Euthyroid Group: Subjects received rhTSH to prepare for radioiodine therapy.
 Drug: Euthyroid Group
Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.
Other Name: Recombinant Human TSH (rhTSH)
No Intervention: Hypothyroid Group
Hypothyroid Group: Thyroid hormone treatment was withheld before radioiodine therapy.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity [ Time Frame: 21 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181168


Locations
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United States, Maryland
Johns Hopkins Division of Endocrinology & Metabolism
Baltimore, Maryland, United States, 21287
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
France
Institute Gustave Roussy
Paris, France
Sponsors and Collaborators
Johns Hopkins University
Gustave Roussy, Cancer Campus, Grand Paris
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Paul W Ladenson, MD Johns Hopkins University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181168    
Other Study ID Numbers: THYR01105ORP
JHM IRB #1 ( Other Identifier: Johns Hopkins University )
First Posted: September 16, 2005    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: October 2018
Keywords provided by Johns Hopkins University:
thyroid cancer
PET scan
recombinant thyrotropin
thyroglobulin
Thyroid cancer, differentiated epithelial
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
 Neoplasms by Site
Neoplasms
Head and Neck Neoplasms