Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age less than 18 years.
Patients who are pregnant.
Trial design
Design model
Single group
Treatments tested in this trial
PET/CT Scan
DeviceUp to four whole-body PET scans (approximately 24, 48, and 120 hours post 124I oral dose) will be performed on one of the GE Discovery 710 or 690 PET scanners.
Iodine-124
DrugPatients will receive 0.9 mg injections of rhTSH on two consecutive days. Twenty-four hours after the last injection of rhTSH each patient will receive approximately 5 mCi (range: 4-7 mCi) of 124I orally as a single dose. (If a holiday is present in the work week, 124I can be administered orally on Day 2, if needed).
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Lesion Dosimetry With Iodine-124Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
number of individual lesions response
This will be accomplished using a logistic regression model using lesion as the unit of analysis and adjusting for possible correlation between lesions on the same patient using a random effect at the patient level. by RECIST 1.1
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov