Trial Outcomes & Findings for Pre-Operative Nodal Staging of Thyroid Cancer Using USPIO MRI: Preliminary Study (NCT NCT01927887)
NCT ID: NCT01927887
Last Updated: 2017-06-06
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
2 Years
Results posted on
2017-06-06
Participant Flow
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
Participant milestones
| Measure |
Lymphotrophic Superparamagnetic Nanoparticles (LSN 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.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.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-Operative Nodal Staging of Thyroid Cancer Using USPIO MRI: Preliminary Study
Baseline characteristics by cohort
| Measure |
Nanoparticle Enhanced MRI
n=12 Participants
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
|
|---|---|
|
Age, Continuous
|
42 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 YearsUsing 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
Outcome measures
| Measure |
Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
n=12 Participants
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
|
|---|---|
|
Primary Efficacy Parameters of Sensitivity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
|
85.5 percentage of excised nodes
Interval 75.7 to 92.0
|
PRIMARY outcome
Timeframe: 2 yearsUsing 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.
Outcome measures
| Measure |
Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
n=12 Participants
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
|
|---|---|
|
Primary Efficacy Parameters of Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
|
89.3 percentage of true negative nodes
Interval 85.4 to 92.4
|
Adverse Events
Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place