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Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma

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ClinicalTrials.gov Identifier: NCT03647358
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE August 22, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE August 21, 2018
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
number of individual lesions response [ Time Frame: 1 year ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03647358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Thyroid Carcinoma
  • Metastatic Thyroid Carcinoma
Intervention  ICMJE
  • Device: PET/CT Scan
    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.
  • Drug: Iodine-124
    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.
Study Arms  ICMJE 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.
Interventions:
  • Device: PET/CT Scan
  • Drug: Iodine-124
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult thyroid carcinoma patients who have had a total thyroidectomy, histology confirmed by pathology.
  • 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.
  • 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 non-contrast CT scanning.

Exclusion Criteria:

  • Age less than 18 years.
  • Patients who are pregnant.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ravinder Grewal, MD 212-639-2872 grewalr@mskcc.org
Contact: Steven Larson, MD 646-888-2212
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03647358
Other Study ID Numbers  ICMJE 18-253
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ravinder Grewal, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP