Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Gustave Roussy, Cancer Campus, Grand Paris
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181168
First received: September 12, 2005
Last updated: September 24, 2007
Last verified: September 2007
  Purpose

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
Thyroid Cancer
Drug: Recombinant thyrotropin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • PET-CT fusion scanning after rTSH will be more sensitive to detect disease sites than scanning without rTSH; this information will significantly alter the therapeutic approach in some patients.

Secondary Outcome Measures:
  • Increase in FDG PET SUV after rTSH will be more specific for metastases than for nonneoplastic processes (e.g., infection and muscle contraction).

Estimated Enrollment: 70
Study Start Date: March 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181168

Contacts
Contact: Paul W Ladenson, MD 410-955-3663 ladenson@jhmi.edu
Contact: Marge E Ewertz, RN 410-955-1667 meewertz@jhmi.edu

Locations
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         
Sponsors and Collaborators
Johns Hopkins University
Gustave Roussy, Cancer Campus, Grand Paris
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Paul W Ladenson, MD Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00181168     History of Changes
Other Study ID Numbers: THYR01105ORP, JHM IRB #1
Study First Received: September 12, 2005
Last Updated: September 24, 2007
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency

Keywords provided by Johns Hopkins University:
thyroid cancer
PET scan
recombinant thyrotropin
thyroglobulin
Thyroid cancer, differentiated epithelial

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 01, 2014