Trial Outcomes & Findings for GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer (NCT NCT01176513)
NCT ID: NCT01176513
Last Updated: 2014-02-14
Results Overview
Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.
TERMINATED
PHASE2
25 participants
After GE-148 (18F) Injection administration.
2014-02-14
Participant Flow
25 subjects were enrolled in this study and 3 subjects withdrew prior to dosing with this product. As a result, 22 subjects were used in the analysis for this study.
Participant milestones
| Measure |
GE 148-002
GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
GE 148-002
GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
|
|---|---|
|
Overall Study
Withdrew subjects prior to dosing
|
3
|
Baseline Characteristics
GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
GE 148-002
n=22 Participants
GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 6.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After GE-148 (18F) Injection administration.Population: Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.
Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: After GE-148 (18F) Injection administrationPopulation: Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.
Use of descriptive statistics to compare the ability of the PET/CT imaging and MRI to predict malignancy, based on histopathology as the standard of truth, on a subject basis and per lesion basis.
Outcome measures
Outcome data not reported
Adverse Events
GE 148-002
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GE 148-002
n=22 participants at risk
GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.
|
|---|---|
|
Nervous system disorders
Dysgeusia
|
9.1%
2/22 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place