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Trial record 55 of 116 for:    medullary carcinoma

Pre-Operative Nodal Staging of Thyroid Cancer Using USPIO MRI: Preliminary Study

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ClinicalTrials.gov Identifier: NCT01927887
Recruitment Status : Completed
First Posted : August 23, 2013
Results First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Mukesh Harisinghani, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Papillary Carcinoma of Thyroid Gland
Metastatic Medullary Thyroid Cancer
Follicular Thyroid Cancer Lymph Node Metastasis
Interventions Drug: Ferumoxytol
Device: Nanoparticle MRI
Enrollment 12
Recruitment Details The proposed accrual goal for the study was to enroll 20 patients, who meet the inclusion criterion. 12 patients who met criteria were identified, enrolled and completed study as outlined in the protocol
Pre-assignment Details  
Arm/Group Title Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
Hide Arm/Group Description Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols.Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Nanoparticle Enhanced MRI
Hide Arm/Group Description

Each subject will have one MRI scan at MGH. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed.The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.

Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.

lymphotrophic superparamagnetic nanoparticle

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
42  (10)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
7
  58.3%
Male
5
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Primary Efficacy Parameters of Sensitivity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
Hide Description Using pathology as the gold standard the excised nodes will be correlated to histopathologic assessment and the primary efficacy parameters of LSN MRI will be determined for nodal staging
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
Hide Arm/Group Description:

Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.

Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.

lymphotrophic superparamagnetic nanoparticle

Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of excised nodes
85.5
(75.7 to 92)
2.Primary Outcome
Title Primary Efficacy Parameters of Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
Hide Description Using pathology as the gold standard the excised nodes will be correlated to histopathologic assessment and the primary efficacy parameters of LSN MRI will be determined for nodal staging. Specificity was determined by assessing the percentage of true negative nodes using pathology as a gold standard.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nanoparticle MRI
Hide Arm/Group Description:
Nanoparticle MRI: Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of true negative nodes
89.3
(85.4 to 92.4)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
Hide Arm/Group Description

Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.

Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.

lymphotrophic superparamagnetic nanoparticle

All-Cause Mortality
Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mukesh Harisinghani
Organization: Massachusetts General Hospital
Phone: 6176432009
EMail: mharisinghani@partners.org
Layout table for additonal information
Responsible Party: Mukesh Harisinghani, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01927887     History of Changes
Other Study ID Numbers: 12-132
First Submitted: August 20, 2013
First Posted: August 23, 2013
Results First Submitted: January 24, 2017
Results First Posted: June 6, 2017
Last Update Posted: June 6, 2017