Clinical trial · Interventional
Evaluation of Thyroid Stunning From a Diagnostic Dose of I-123
NCT02278198CI-TRIAL-00041283completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to find out if the small dose of radioiodine, that is used for the dosimetry study on patients with differentiated thyroid cancer, may stun the cancer cells and make the thyroid cancer treatment less effective.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Thyroid Cancer | Thyroid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rhTSH | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Differentiated Thyroid Cancer
- description
- All patients will receive one extra imaging scan with I-123 in addition to their routine care as described above. This research portion of their care will be similar to the scan that they undergo for the I-123 planning scan that is already a part of their routine care. The research study, which will be performed in the middle of the patient's normal standard of care treatment, will take 4 days. On days 1 and 2, all patients will receive a intramuscular injection of rhTSH (Thyrogen). On day 3, all patients will be given 3 mCi of I-123 in the form of a pill to take by mouth. On day 4, all patients will receive a I-123 Whole Body Imaging Scan and a thyroid camera scan of the neck and thigh.
- interventionNames
- Drug: rhTSH
Primary outcomes (1)
- measure
- Difference in uptake of I-123 in the thyroid remnant in the neck in the two imaging studies.
- timeFrame
- 11 days
- description
- Greater than a 20% decrease from the first to second study will indicate evidence of stunning.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must be 21-years-old or greater. * Patient must be status post near total thyroidectomy for differentiated thyroid cancer without known distant metastases and who are planning to undergo routine remnant thyroid tissue ablation with I-131. * Patients must qualify for thyroid ablation with I-131. Exclusion Criteria: * Women who are pregnant or breastfeeding. * Prior bovine TSH use. * Known metastatic thyroid cancer. * History of cardiovascular disease that may adversely affect patient participation at the discretion of the primary investigator. * Patients on hemodialysis. * Patients with acute serious illnesses at the discretion of the primary investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.