Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03647358
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Thyroid Carcinoma
  • Thyroid Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PET/CT Scan — DEVICE
    Up 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 — DRUG
    Patients 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).

Study Details

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.

Key Dates

Start date
Aug 21, 2018
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Lesion Dosimetry With Iodine-124
    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.

Primary Outcome Measure

number of individual lesions response [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Ravinder Grewal, MD
212-639-2872
Steven Larson, MD
646-888-2212
Ravinder Grewal, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Memorial Sloan Kettering Cancer Center· New York, NY

Related Studies