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Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

Primary Purpose

Thyroid Carcinoma, Metastatic Thyroid Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PET/CT Scan
Iodine-124
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Carcinoma focused on measuring Iodine-124, PET Scan, 18-253

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Weill Cornell Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lesion Dosimetry With Iodine-124

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 22, 2018
Last Updated
May 31, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03647358
Brief Title
Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma
Official Title
Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2018 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Carcinoma, Metastatic Thyroid Carcinoma
Keywords
Iodine-124, PET Scan, 18-253

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lesion Dosimetry With Iodine-124
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
PET/CT Scan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Iodine-124
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of individual lesions response
Description
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 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ravinder Grewal, MD
Phone
212-639-2872
Email
grewalr@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Larson, MD
Phone
646-888-2212
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravinder Grewal, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravinder Grewal, MD
Phone
212-639-2872
First Name & Middle Initial & Last Name & Degree
Steven Larson, MD
Phone
646-888-2212
First Name & Middle Initial & Last Name & Degree
Ravinder Grewal, MD
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Osborne, MD, PhD
Phone
212-746-6000

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

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