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Sponsors and Collaborators: |
Johns Hopkins University Institut Gustave Roussy M.D. Anderson Cancer Center Genzyme |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00181168 |
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 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 | Intervention | Phase |
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Thyroid Cancer |
Drug: Recombinant thyrotropin |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety Study |
Official Title: | Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-Differentiated Epithelial Thyroid Cancer |
Estimated Enrollment: | 70 |
Study Start Date: | March 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul W Ladenson, MD | 410-955-3663 | ladenson@jhmi.edu |
Contact: Marge E Ewertz, RN | 410-955-1667 | meewertz@jhmi.edu |
United States, Maryland | |
Johns Hopkins Division of Endocrinology & Metabolism | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Paul W Ladenson, MD 410-955-3663 ladenson@jhmi.edu | |
Contact: Marge E Ewertz, RN 410-955-1667 meewertz@jhmi.edu | |
Principal Investigator: Paul W Ladenson, MD | |
United States, Texas | |
M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Steven I Sherman, MD sisherma@mail.mdanderson.org | |
Principal Investigator: Steven I Sherman, MD | |
France | |
Institute Gustave Roussy | Recruiting |
Paris, France | |
Contact: Martin Schlumberger, MD schlumbg@igr.fr | |
Principal Investigator: Martin Schlumberger, MD | |
Sub-Investigator: Sophie Leboulleux, MD |
Principal Investigator: | Paul W Ladenson, MD | Johns Hopkins University |
Study ID Numbers: | THYR01105ORP, JHM IRB #1 |
Study First Received: | September 12, 2005 |
Last Updated: | September 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00181168 |
Health Authority: | United States: Institutional Review Board; European Union: European Medicines Agency |
thyroid cancer PET scan recombinant thyrotropin thyroglobulin Thyroid cancer, differentiated epithelial |
Thyroid Neoplasms Head and Neck Neoplasms Endocrine System Diseases |
Endocrinopathy Thyroid Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site |