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| ID | Type | Description | Link |
|---|---|---|---|
| JHM IRB #1 | Other Identifier | Johns Hopkins University |
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| Name | Class |
|---|---|
| Gustave Roussy, Cancer Campus, Grand Paris | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| Genzyme, a Sanofi Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Euthyroid Group | Experimental | Euthyroid Group: Subjects received rhTSH to prepare for radioiodine therapy. |
|
| Hypothyroid Group | No Intervention | Hypothyroid Group: Thyroid hormone treatment was withheld before radioiodine therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euthyroid Group | Drug | Euthyroid Group: Received rhTSH to prepare for radioiodine therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity | 21 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul W Ladenson, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Division of Endocrinology & Metabolism | Baltimore | Maryland | 21287 | United States | ||
| M.D. Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14715833 | Background | 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. | |
| 16384850 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Euthyroid Group | Subjects received rhTSH to prepare for radioiodine therapy |
| FG001 | Hypothyroid Group | Thyroid hormone treatment was withheld before radioiodine therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Euthyroid Group | Adults (age >18 years) with a history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hürthle 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. Subjects received rhTSH to prepare for radioiodine therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 21 Days |
|
21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Euthyroid Group | Adults (age >18 years) with a history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hürthle 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. Subjects received rhTSH to prepare for radioiodine therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul W. Ladenson, MD, Professor and PI | Johns Hopkins Univ | 4109553663 | ladenson@jhmi.edu |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D057073 | Thyrotropin Alfa |
| ID | Term |
|---|---|
| D013972 | Thyrotropin |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| Houston |
| Texas |
| 77030 |
| United States |
| Institute Gustave Roussy | Paris | France |
| 19158200 | Result | 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. |
| BG001 | Hypothyroid Group | Adults (age >18 years) with a history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hürthle 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. Thyroid hormone treatment was withheld before radioiodine therapy. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity | Not Posted | 21 Days | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Hypothyroid Group | Adults (age >18 years) with a history of treated well-differentiated epithelial thyroid carcinoma (papillary, follicular, or Hürthle 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. Thyroid hormone treatment was withheld before radioiodine therapy. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |