Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
Conditions
Thyroid Cancer
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
thyroid cancer, PET scan, recombinant thyrotropin, thyroglobulin, Thyroid cancer, differentiated epithelial
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Recombinant thyrotropin
Type: Drug
Overall Status
Recruiting
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Johns Hopkins Division of Endocrinology & Metabolism
Baltimore, Maryland, United States
Status: Recruiting
Contact: Paul W Ladenson, MD - 410-955-3663 - ladenson@jhmi.edu
M.D. Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Steven I Sherman, MD - sisherma@mail.mdanderson.org
Institute Gustave Roussy
Paris, France
Status: Recruiting
Contact: Martin Schlumberger, MD - schlumbg@igr.fr
Start Date
March 2005
Sponsors
Johns Hopkins University
Source
Johns Hopkins University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page