Recombinant Thyrotropin PET-CT Fusion Scanning in Thyroid Cancer
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| ClinicalTrials.gov Identifier: NCT00181168 |
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Recruitment Status
: Unknown
Verified September 2007 by Johns Hopkins University.
Recruitment status was: Recruiting
First Posted
: September 16, 2005
Last Update Posted
: September 26, 2007
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Sponsor:
Johns Hopkins University
Collaborators:
Gustave Roussy, Cancer Campus, Grand Paris
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Information provided by:
Johns Hopkins University
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Thyroid Cancer | Drug: Recombinant thyrotropin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 70 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (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 |
| Study Start Date : | March 2005 |
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
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- Increase in FDG PET SUV after rTSH will be more specific for metastases than for nonneoplastic processes (e.g., infection and muscle contraction).
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Gustave Roussy, Cancer Campus, Grand Paris
M.D. Anderson Cancer Center
Genzyme, a Sanofi Company
Investigators
| Principal Investigator: | Paul W Ladenson, MD | Johns Hopkins University |
Publications:
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 |
| First Posted: | September 16, 2005 Key Record Dates |
| Last Update Posted: | September 26, 2007 |
| Last Verified: | September 2007 |
Keywords provided by Johns Hopkins University:
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thyroid cancer PET scan recombinant thyrotropin thyroglobulin Thyroid cancer, differentiated epithelial |
Additional relevant MeSH terms:
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Thyroid Diseases Thyroid Neoplasms Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site |
Neoplasms Head and Neck Neoplasms Calcitonin Bone Density Conservation Agents Physiological Effects of Drugs |