Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

Brief Title

Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

Official Title

Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

Brief Summary

      The purpose of this study is to evaluate a new diagnostic imaging test, positron emission
      tomography (PET), with a different radioactive form of iodine called iodine-124. This form is
      able to accurately measure the amount of radioactive iodine uptake in the cancer. If the new
      test determines sufficient radioiodine uptake in the cancer, treatment will continue as
      usual. However, if the new test shows only low radioiodine uptake, a decision may be made
      that the benefit from radioiodine therapy is insufficient and that another form of therapy is
      preferred.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

number of individual lesions response

Condition

Thyroid Carcinoma

Intervention

PET/CT Scan

Study Arms / Comparison Groups

 Lesion Dosimetry With Iodine-124

Description:  Patients will be administered 124I and undergo serial PET imaging consisting of up to 4 individual PET/CT scans. In order to perform a dual exponential fit, 4 scans are needed to obtain the necessary amount of data points required. Lesion dosimetry shall be performed based on the 124I PET scan data through tumor uptake and clearance pharmacokinetics. 10 patients, who sign consent for the sub-study, will be administered an additional tracer diagnostic activity of 124I (4 to 7 mCi). These patients will then undergo additional (up to a maximum of 4) PET scanning during radioiodine therapy at time points matched, if possible, to the days of the pre-therapy 124I dosimetry study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

60

Start Date

August 21, 2018

Completion Date

August 2023

Primary Completion Date

August 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Adults with thyroid carcinoma confirmed by pathology.

          -  Adult thyroid carcinoma patients who have undergone total thyroidectomy

          -  Adult thyroid carcinoma patients have metastatic disease or suspicion for metastatic
             disease, or are under a protocol intended to explore re-induction therapy for 131I
             uptake, and are about to undergo Thyrogen-assisted dosimetry, unless Thyrogen-assisted
             dosimetry is not required per standard of care.

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

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

        Exclusion Criteria:

          -  Age less than 18 years.

          -  Patients who are pregnant.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ravinder Grewal, MD, 212-639-2872, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT03647358

Organization ID

18-253

Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center

Study Sponsor

Ravinder Grewal, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

Verification Date

August 2022