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Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Thyroid Cancer

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Trial Information

Lesion Dosimetry With 124-Iodine in Metastatic Thyroid Carcinoma


Inclusion Criteria:



- Adult thyroid carcinoma patients who have had a total thyroidectomy, histology
confirmed by an MSKCC attending pathologist, and radioiodine remnant ablation.

- Adult thyroid carcinoma patients who have previously demonstrated radioiodine-avid
metastases and are about to undergo Thyrogen-assisted dosimetry at MSKCC.

- The patient and physician are planning to administer 131-I for therapy if persistent
radioiodine-avid metastases are present.

- Men and women of all races, ethnicities, and religious backgrounds are eligible.

- All subjects must have measurable disease, documented within the previous six months
by ultrasonography (US), MRI, or non-contrast CT scanning.

Exclusion Criteria:

- Thyroid cancer patients who do not have metastases.

- Thyroid cancer patients who have not demonstrated that their metastases concentrate
radioiodine.

- Patients who are under therapy for other active cancers.

- Anaplastic or Medullary thyroid carcinoma.

- Age less than 18 years.

- Patient who have received a therapeutic dose of radioiodine within the preceding nine
months will not be eligible.

- Patients who plan to withdraw from thyroid hormone prior to dosimetry.

- Patients who are pregnant.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To estimate the relationship between the radiation dose and response to radiation at one year for metastatic lesions arising from differentiated thyroid carcinoma, following a single therapeutic administration of 131-Iodine.

Outcome Time Frame:

conclusion of the study

Safety Issue:

Yes

Principal Investigator

Ravinder Grewal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

04-116

NCT ID:

NCT00673010

Start Date:

March 2005

Completion Date:

March 2014

Related Keywords:

  • Thyroid Cancer
  • 124-IODINE
  • I-131 METAIODOBENZ SULF (MIBG)
  • Thyroid
  • Parathyroid
  • Carcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021