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

First Received on September 12, 2005. Last Updated on September 24, 2007 History of Changes

Sponsor:	Johns Hopkins University
Collaborators:	Institut Gustave Roussy M.D. Anderson Cancer Center Genzyme
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00181168

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 II

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:

MedlinePlus related topics: Cancer Nuclear Scans Thyroid Cancer Thyroid Diseases

Drug Information available for: Thyroid Thyrotropin

U.S. FDA Resources

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

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

Institut Gustave Roussy

M.D. Anderson Cancer Center

Genzyme

Investigators

Principal Investigator:

Paul W Ladenson, MD

Johns Hopkins University

More Information

Publications:

Chin BB, Patel P, Cohade C, Ewertz M, Wahl R, Ladenson P. Recombinant human thyrotropin stimulation of fluoro-D-glucose positron emission tomography uptake in well-differentiated thyroid carcinoma. J Clin Endocrinol Metab. 2004 Jan;89(1):91-5.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leboulleux S, Schroeder PR, Busaidy NL, Auperin A, Corone C, Jacene HA, Ewertz ME, Bournaud C, Wahl RL, Sherman SI, Ladenson PW, Schlumberger M. Assessment of the incremental value of recombinant thyrotropin stimulation before 2-[18F]-Fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography imaging to localize residual differentiated thyroid cancer. J Clin Endocrinol Metab. 2009 Apr;94(4):1310-6. Epub 2009 Jan 21.

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 February 09, 2012