Back to resultsRecombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
Primary Purpose
Thyroid Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Euthyroid Group
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Cancer focused on measuring thyroid cancer, PET scan, recombinant thyrotropin, thyroglobulin, Thyroid cancer, differentiated epithelial
Eligibility 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
Sites / Locations
- Johns Hopkins Division of Endocrinology & Metabolism
- M.D. Anderson Cancer Center
- Institute Gustave Roussy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Euthyroid Group
Hypothyroid Group
Arm Description
Euthyroid Group: Subjects received rhTSH to prepare for radioiodine therapy.
Hypothyroid Group: Thyroid hormone treatment was withheld before radioiodine therapy.
Outcomes
Primary Outcome Measures
PET-CT Fusion Scanning Sensitivity
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
Full Information
NCT ID
NCT00181168
First Posted
September 12, 2005
Last Updated
October 30, 2018
Sponsor
Johns Hopkins University
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris, M.D. Anderson Cancer Center, Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00181168
Brief Title
Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
Official Title
Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-differentiated Epithelial Thyroid Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Gustave Roussy, Cancer Campus, Grand Paris, M.D. Anderson Cancer Center, Genzyme, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
thyroid cancer, PET scan, recombinant thyrotropin, thyroglobulin, Thyroid cancer, differentiated epithelial
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Euthyroid Group
Arm Type
Experimental
Arm Description
Euthyroid Group: Subjects received rhTSH to prepare for radioiodine therapy.
Arm Title
Hypothyroid Group
Arm Type
No Intervention
Arm Description
Hypothyroid Group: Thyroid hormone treatment was withheld before radioiodine therapy.
Intervention Type
Drug
Intervention Name(s)
Euthyroid Group
Other Intervention Name(s)
Recombinant Human TSH (rhTSH)
Intervention Description
Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.
Primary Outcome Measure Information:
Title
PET-CT Fusion Scanning Sensitivity
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.
Time Frame
21 Days
Secondary Outcome Measure Information:
Title
Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity
Time Frame
21 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul W Ladenson, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Division of Endocrinology & Metabolism
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Institute Gustave Roussy
City
Paris
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
14715833
Citation
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. doi: 10.1210/jc.2003-031027.
Results Reference
background
PubMed Identifier
16384850
Citation
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. doi: 10.1210/jc.2005-1651. Epub 2005 Dec 29.
Results Reference
result
PubMed Identifier
19158200
Citation
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.
Results Reference
result
Learn more about this trial
Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
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