Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

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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:  Pts will be administered 124I & undergo serial PET imaging consisting of up to 4 individual PET/CT scans. In a set of 10 pts, consent will be sought to obtain additional PET/CT scans during the week of 131I therapy. In this study group, patients will receive an additional 4 to 7 mCi 124I tracer dose, alongside the 131I radioiodine therapy dose, for the purpose of imaging radioiodine lesional uptake during therapy. This will be the first study to compare the predicted lesion radiation absorbed doses in Gray derived from a pre-therapy test imaging dose to an imaging dose administered concomitant with 131I radioiodine therapy. Pts will be taken off-treatment on day 8, as days 9 & 10 are standard of care intervention. Subjects receiving RAI therapy may remain on-study & be followed for up to 1.5 years with standard of care anatomical imaging, or until they receive their next standard of care anatomical imaging (PET, CT, MRI, ultrasound) or are deemed lost to follow up by the study doctor.

Publications

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

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

100

Start Date

August 21, 2018

Completion Date

August 2022

Primary Completion Date

August 2022

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

Administrative Informations


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

December 2020