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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

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.

Condition or disease Intervention/treatment Phase
Thyroid Carcinoma Metastatic Thyroid Carcinoma Device: PET/CT Scan Drug: Iodine-124 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma
Actual Study Start Date : August 21, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647358


Contacts
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Contact: Ravinder Grewal, MD 212-639-2872 grewalr@mskcc.org
Contact: Steven Larson, MD 646-888-2212

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Ravinder Grewal, MD    212-639-2872      
Contact: Steven Larson, MD    646-888-2212      
Principal Investigator: Ravinder Grewal, MD         
Weill Cornell Medical Center Not yet recruiting
New York, New York, United States, 10065
Contact: Joseph Osborne, MD, PhD    212-746-6000      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Ravinder Grewal, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03647358     History of Changes
Other Study ID Numbers: 18-253
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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

Keywords provided by Memorial Sloan Kettering Cancer Center:
Iodine-124
PET Scan
18-253

Additional relevant MeSH terms:
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Carcinoma
Thyroid Neoplasms
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs