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

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


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

MedlinePlus related topics: Nuclear Scans Thyroid Cancer Thyroid Diseases

Drug Information available for: Thyroid

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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


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


Principal Investigator:	Paul W Ladenson, MD	Johns Hopkins University

More Information

Publications of Results:

Pacini F, Ladenson PW, Schlumberger M, Driedger A, Luster M, Kloos RT, Sherman S, Haugen B, Corone C, Molinaro E, Elisei R, Ceccarelli C, Pinchera A, Wahl RL, Leboulleux S, Ricard M, Yoo J, Busaidy NL, Delpassand E, Hanscheid H, Felbinger R, Lassmann M, Reiners C. Radioiodine ablation of thyroid remnants after preparation with recombinant human thyrotropin in differentiated thyroid carcinoma: results of an international, randomized, controlled study. J Clin Endocrinol Metab. 2006 Mar;91(3):926-32. Epub 2005 Dec 29.

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. doi: 10.1210/jc.2008-1747. Epub 2009 Jan 21.

Other 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.


Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00181168 History of Changes
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:


Thyroid Diseases Thyroid Neoplasms Endocrine System Diseases Endocrine Gland Neoplasms	Neoplasms by Site Neoplasms Head and Neck Neoplasms

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