- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03647358
Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma
April 2, 2024 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ravinder Grewal, MD
- Phone Number: 212-639-2872
- Email: grewalr@mskcc.org
Study Contact Backup
- Name: Steven Larson, MD
- Phone Number: 646-888-2212
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Steven Larson, MD
- Phone Number: 646-888-2212
-
Contact:
- Ravinder Grewal, MD
- Phone Number: 212-639-2872
-
Principal Investigator:
- Ravinder Grewal, MD
-
New York, New York, United States, 10065
- Not yet recruiting
- Weill Cornell Medical Center
-
Contact:
- Joseph Osborne, MD, PhD
- Phone Number: 212-746-6000
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ravinder Grewal, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2018
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
August 22, 2018
First Submitted That Met QC Criteria
August 23, 2018
First Posted (Actual)
August 27, 2018
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-253
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thyroid Carcinoma
-
National Cancer Institute (NCI)ExelixisCompletedRecurrent Thyroid Gland Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | Stage I Thyroid Gland Papillary Carcinoma | Stage II Thyroid Gland Papillary Carcinoma | Stage III Thyroid Gland Papillary Carcinoma | Tall Cell Variant Thyroid Gland Papillary Carcinoma | Stage I Thyroid Gland... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingPoorly Differentiated Thyroid Gland Carcinoma | Thyroid Gland Squamous Cell Carcinoma | Unresectable Thyroid Gland Carcinoma | Metastatic Thyroid Gland Carcinoma | Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8 | Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8United States
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Thyroid Gland Carcinoma | Refractory Thyroid Gland Carcinoma | Stage III Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 | Stage... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)CompletedPoorly Differentiated Thyroid Gland Carcinoma | Recurrent Differentiated Thyroid Gland Carcinoma | Columnar Cell Variant Thyroid Gland Papillary Carcinoma | Follicular Variant Thyroid Gland Papillary Carcinoma | Metastatic Thyroid Gland Follicular Carcinoma | Metastatic Thyroid Gland Papillary... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRefractory Differentiated Thyroid Gland Carcinoma | Unresectable Thyroid Gland Carcinoma | Refractory Thyroid Gland Papillary Carcinoma | Refractory Thyroid Gland Follicular Carcinoma | Refractory Thyroid Gland Hurthle Cell CarcinomaUnited States, Canada
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingPoorly Differentiated Thyroid Gland Carcinoma | Thyroid Gland Anaplastic Carcinoma | Unresectable Thyroid Gland Carcinoma | Metastatic Thyroid Gland Carcinoma | Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8 | Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8 | Stage IVA Thyroid Gland...United States
-
National Cancer Institute (NCI)Active, not recruitingPoorly Differentiated Thyroid Gland Carcinoma | Refractory Differentiated Thyroid Gland Carcinoma | Refractory Thyroid Gland Carcinoma | Follicular Variant Thyroid Gland Papillary Carcinoma | Tall Cell Variant Thyroid Gland Papillary Carcinoma | Differentiated Thyroid Gland Carcinoma | Thyroid... and other conditionsUnited States
-
Grupo Espanol de Tumores NeuroendocrinosMFARActive, not recruitingMetastatic Thyroid Cancer | Metastatic Thyroid Papillary Carcinoma | Metastatic Thyroid Follicular CarcinomaSpain
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Thyroid Gland Carcinoma | Poorly Differentiated Thyroid Gland Carcinoma | Refractory Thyroid Gland Carcinoma | Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 | Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 | Stage IVA Thyroid... and other conditionsUnited States
-
Saint Petersburg State University, RussiaWithdrawnPoorly Differentiated Thyroid Gland Carcinoma | Metastatic Thyroid Gland Carcinoma | Thyroid Gland Anaplastic Carcinoma by AJCC V8 StageRussian Federation
Clinical Trials on PET/CT Scan
-
University of UtahNational Cancer Institute (NCI)CompletedFluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) in Cancer Associated VenothromboembolismVenothromboembolismUnited States
-
HALO DiagnosticsCompletedProstate CancerUnited States
-
Radboud University Medical CenterUnknownCarcinoma, Non Small Cell LungNetherlands
-
University of RochesterTerminatedChronic Graft Versus Host DiseaseUnited States
-
Guy's and St Thomas' NHS Foundation TrustKing's College LondonRecruiting
-
Colchester General HospitalAnglia Ruskin UniversityUnknownRectal NeoplasmsUnited Kingdom
-
Ontario Clinical Oncology Group (OCOG)Ontario Ministry of Health and Long Term CareCompletedLymphoma | Breast Cancer | Head and Neck Cancer | Esophageal Cancer | Ovarian Cancer | Non-small Cell Lung CancerCanada
-
GE HealthcareLaboratory Corporation of AmericaNot yet recruiting
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedNon-Hodgkin's Lymphoma | Lung CancerUnited States
-
University of ArizonaBlue Earth Diagnostics; Banner University Medical CenterCompletedProstate AdenocarcinomaUnited States