Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
Study Details
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 |
|---|---|---|
|
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
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 Names:
|
| No Intervention: Hypothyroid Group Hypothyroid Group: Thyroid hormone treatment was withheld before radioiodine therapy. |
Outcome Measures
Primary Outcome Measures
- PET-CT Fusion Scanning Sensitivity [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 [21 Days]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins Division of Endocrinology & Metabolism | Baltimore | Maryland | United States | 21287 |
| 2 | M.D. Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 3 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- THYR01105ORP
- JHM IRB #1
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Euthyroid Group | Hypothyroid Group |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Euthyroid Group | Hypothyroid Group | Total |
|---|---|---|---|
| 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 Participants | 30 | 33 | 63 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
30
100%
|
33
100%
|
63
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
24
80%
|
26
78.8%
|
50
79.4%
|
| Male |
6
20%
|
7
21.2%
|
13
20.6%
|
| Region of Enrollment (participants) [Number] | |||
| France |
13
43.3%
|
14
42.4%
|
27
42.9%
|
| United States |
17
56.7%
|
19
57.6%
|
36
57.1%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Euthyroid Group | Hypothyroid Group |
|---|---|---|
| Arm/Group Description | Subjects received rhTSH to prepare for radioiodine therapy. | Thyroid hormone treatment was withheld before radioiodine therapy. |
| Measure Participants | 30 | 33 |
| Number (95% Confidence Interval) [percentage of participants] |
49
163.3%
|
54
163.6%
|
| Title | Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity |
|---|---|
| Description | |
| Time Frame | 21 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | 21 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Euthyroid Group | Hypothyroid Group | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/33 (0%) | ||
Serious Adverse Events |
||||
| Euthyroid Group | Hypothyroid Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/33 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Euthyroid Group | Hypothyroid Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/33 (0%) | ||
Limitations/Caveats
More Information
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 |
| ladenson@jhmi.edu |
- THYR01105ORP
- JHM IRB #1