Trial Outcomes & Findings for Iodine I 131 in Treating Patients With Thyroid Cancer (NCT NCT00416949)
NCT ID: NCT00416949
Last Updated: 2018-07-18
Results Overview
Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
up to 4 years
Results posted on
2018-07-18
Participant Flow
Participant milestones
| Measure |
Patient-specific 3D-RD Dosimetry
Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Patient-specific 3D-RD Dosimetry
Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
|
|---|---|
|
Overall Study
Patients refused to participate
|
5
|
Baseline Characteristics
Iodine I 131 in Treating Patients With Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Patient-specific 3D-RD Dosimetry
n=9 Participants
Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 4 yearsPopulation: Was only able to analyze tumor data from 3 patients based on number of tumors that could be reliably imaged for analysis.
Tumor absorbed doses (Gy) calculated using patient-specific dosimetry.
Outcome measures
| Measure |
Patient-specific 3D-RD Dosimetry
n=5 number of tumors
Applied a patient-specific dosimetry calculation method to the imaging data collected to calculate tumor absorbed doses, using 3D-RD method.
|
|---|---|
|
Tumor Absorbed Dose
|
6.6 Gy
Standard Deviation 4.54
|
Adverse Events
Patient-specific 3D-RD Dosimetry
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