Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Johns Hopkins University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Johns Hopkins University
Collaborators:
Institut Gustave Roussy
M.D. Anderson Cancer Center
Genzyme
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181168
First received: September 12, 2005
Last updated: September 24, 2007
Last verified: September 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Thyroid Cancer |
Drug: Recombinant thyrotropin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Utility of Recombinant Human Thyrotropin (rTSH) PET-CT Fusion Scanning to Identify Residual Well-Differentiated Epithelial Thyroid Cancer |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- 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 Measures:
- Increase in FDG PET SUV after rTSH will be more specific for metastases than for nonneoplastic processes (e.g., infection and muscle contraction).
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181168
Contacts
| Contact: Paul W Ladenson, MD | 410-955-3663 | ladenson@jhmi.edu |
| Contact: Marge E Ewertz, RN | 410-955-1667 | meewertz@jhmi.edu |
Locations
| United States, Maryland | |
| Johns Hopkins Division of Endocrinology & Metabolism | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Paul W Ladenson, MD 410-955-3663 ladenson@jhmi.edu | |
| Contact: Marge E Ewertz, RN 410-955-1667 meewertz@jhmi.edu | |
| Principal Investigator: Paul W Ladenson, MD | |
| United States, Texas | |
| M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Steven I Sherman, MD sisherma@mail.mdanderson.org | |
| Principal Investigator: Steven I Sherman, MD | |
| France | |
| Institute Gustave Roussy | Recruiting |
| Paris, France | |
| Contact: Martin Schlumberger, MD schlumbg@igr.fr | |
| Principal Investigator: Martin Schlumberger, MD | |
| Sub-Investigator: Sophie Leboulleux, MD | |
Sponsors and Collaborators
Johns Hopkins University
Institut Gustave Roussy
M.D. Anderson Cancer Center
Genzyme
Investigators
| Principal Investigator: | Paul W Ladenson, MD | Johns Hopkins University |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00181168 History of Changes |
| Other Study ID Numbers: | THYR01105ORP, JHM IRB #1 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 24, 2007 |
| Health Authority: | United States: Institutional Review Board European Union: European Medicines Agency |
Keywords provided by Johns Hopkins University:
|
thyroid cancer PET scan recombinant thyrotropin thyroglobulin Thyroid cancer, differentiated epithelial |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site |
Neoplasms Head and Neck Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013