Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer

Condition(s) targeted: Thyroid Cancer

Intervention: Recombinant thyrotropin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Paul W Ladenson, MD, Principal Investigator, Affiliation: Johns Hopkins University

Overall contact:
Paul W Ladenson, MD, Phone: 410-955-3663, Email: ladenson@jhmi.edu

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.

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

Study design: Diagnostic, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety Study

Primary outcome: 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.

Secondary outcome: Increase in FDG PET SUV after rTSH will be more specific for metastases than for nonneoplastic processes (e.g., infection and muscle contraction).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Paul W Ladenson, MD, Phone: 410-955-3663, Email: ladenson@jhmi.edu

Institute Gustave Roussy, Paris, France; Recruiting
Martin Schlumberger, MD, Email: schlumbg@igr.fr
Martin Schlumberger, MD, Principal Investigator
Sophie Leboulleux, MD, Sub-Investigator

Johns Hopkins Division of Endocrinology & Metabolism, Baltimore, Maryland 21287, United States; Recruiting
Paul W Ladenson, MD, Phone: 410-955-3663, Email: ladenson@jhmi.edu
Marge E Ewertz, RN, Phone: 410-955-1667, Email: meewertz@jhmi.edu
Paul W Ladenson, MD, Principal Investigator

M.D. Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Steven I Sherman, MD, Email: sisherma@mail.mdanderson.org
Steven I Sherman, MD, Principal Investigator

Related publications:

Chin BB, Patel P, Cohade C, Ewertz M, Wahl R, Ladenson P. Recombinant human thyrotropin stimulation of fluoro-D-glucose positron emission tomography uptake in well-differentiated thyroid carcinoma. J Clin Endocrinol Metab. 2004 Jan;89(1):91-5.

Starting date: March 2005
Last updated: September 24, 2007