Status:
COMPLETED
Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Gustave Roussy, Cancer Campus, Grand Paris
M.D. Anderson Cancer Center
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 p...
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 reader...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00181168
Start Date
March 1 2001
End Date
September 1 2003
Last Update
November 2 2018
Active Locations (3)
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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