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Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-Differentiated Epithelial Thyroid Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Thyroid Cancer

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Trial Information

Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-Differentiated Epithelial Thyroid Cancer


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

PET-CT fusion scanning after rTSH will be more sensitive to detect disease sites than scanning without rTSH; this information will significantly alter the therapeutic approach in some patients.

Principal Investigator

Paul W Ladenson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

THYR01105ORP

NCT ID:

NCT00181168

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Thyroid Cancer
  • thyroid cancer
  • PET scan
  • recombinant thyrotropin
  • thyroglobulin
  • Thyroid cancer, differentiated epithelial
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

M.D. Anderson Cancer CenterHouston, Texas  77030
Johns Hopkins Division of Endocrinology & MetabolismBaltimore, Maryland  21287