Thyroid Cancer
Conditions
Keywords
thyroid cancer, PET scan, recombinant thyrotropin, thyroglobulin, Thyroid cancer, differentiated epithelial
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.
Interventions
DRUGEuthyroid Group
Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity | 21 Days |
Countries
France, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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. | 33 |
| Total | 63 |
Baseline characteristics
| Characteristic | Euthyroid Group | Hypothyroid Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 33 Participants | 63 Participants |
| Region of Enrollment France | 13 participants | 14 participants | 27 participants |
| Region of Enrollment United States | 17 participants | 19 participants | 36 participants |
| Sex: Female, Male Female | 24 Participants | 26 Participants | 50 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 33 |
| other Total, other adverse events | 0 / 30 | 0 / 33 |
| serious Total, serious adverse events | 0 / 30 | 0 / 33 |
Outcome results
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.
Time frame: 21 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Euthyroid Group | PET-CT Fusion Scanning Sensitivity | 49 percentage of participants |
| Hypothyroid Group | PET-CT Fusion Scanning Sensitivity | 54 percentage of participants |
Secondary
Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity
Time frame: 21 Days