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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Thyroid Cancer
Intervention Drug: Euthyroid Group
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Euthyroid Group Hypothyroid Group
Hide Arm/Group Description Subjects received rhTSH to prepare for radioiodine therapy Thyroid hormone treatment was withheld before radioiodine therapy.
Period Title: Overall Study
Started 30 33
Completed 30 33
Not Completed 0 0
Arm/Group Title Euthyroid Group Hypothyroid Group Total
Hide Arm/Group Description

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

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.

Total of all reporting groups
Overall Number of Baseline Participants 30 33 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
33
 100.0%
63
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
Female
24
  80.0%
26
  78.8%
50
  79.4%
Male
6
  20.0%
7
  21.2%
13
  20.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 33 participants 63 participants
France 13 14 27
United States 17 19 36
1.Primary Outcome
Title PET-CT Fusion Scanning Sensitivity
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Euthyroid Group Hypothyroid Group
Hide Arm/Group Description:
Subjects received rhTSH to prepare for radioiodine therapy.
Thyroid hormone treatment was withheld before radioiodine therapy.
Overall Number of Participants Analyzed 30 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49
(36 to 62)
54
(41 to 67)
2.Secondary Outcome
Title Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity
Hide Description [Not Specified]
Time Frame 21 Days
Outcome Measure Data Not Reported
Time Frame 21 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Euthyroid Group Hypothyroid Group
Hide Arm/Group Description

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

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.

All-Cause Mortality
Euthyroid Group Hypothyroid Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/33 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Euthyroid Group Hypothyroid Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Euthyroid Group Hypothyroid Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/33 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Paul W. Ladenson, MD, Professor and PI
Organization: Johns Hopkins Univ
Phone: 4109553663
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 Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: April 21, 2015
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018