Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181168
• Other study ID #: THYR01105ORP
• Secondary ID: JHM IRB #1
• Status: Completed
• Phase: Phase 2
• Start date: March 2001
• Est. completion date: September 2003

Study information

• Verified date: October 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Euthyroid Group
Euthyroid Group: Received rhTSH to prepare for radioiodine therapy.

Locations

Country	Name	City	State
France	Institute Gustave Roussy	Paris
United States	Johns Hopkins Division of Endocrinology & Metabolism	Baltimore	Maryland
United States	M.D. Anderson Cancer Center	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Genzyme, a Sanofi Company, Gustave Roussy, Cancer Campus, Grand Paris, M.D. Anderson Cancer Center

Countries where clinical trial is conducted

United States,  France, 

References & Publications (3)

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. — View Citation

Leboulleux S, Schroeder PR, Busaidy NL, Auperin A, Corone C, Jacene HA, Ewertz ME, Bournaud C, Wahl RL, Sherman SI, Ladenson PW, Schlumberger M. Assessment of the incremental value of recombinant thyrotropin stimulation before 2-[18F]-Fluoro-2-deoxy-D-glu — View Citation

Pacini F, Ladenson PW, Schlumberger M, Driedger A, Luster M, Kloos RT, Sherman S, Haugen B, Corone C, Molinaro E, Elisei R, Ceccarelli C, Pinchera A, Wahl RL, Leboulleux S, Ricard M, Yoo J, Busaidy NL, Delpassand E, Hanscheid H, Felbinger R, Lassmann M, R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	21 Days
Secondary	Increased Fluorodeoxyglucose (FDG) PET Standardized Uptake Value (SUV) After rTSH Specificity		21 Days