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
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|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer||Drug: Euthyroid Group||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity [ Time Frame: 21 Days ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|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|
|Institute Gustave Roussy|
|Principal Investigator:||Paul W Ladenson, MD||Johns Hopkins University|
|Responsible Party:||Johns Hopkins University|
|Other Study ID Numbers:||
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|
Thyroid cancer, differentiated epithelial
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms