Trial Outcomes & Findings for Benefits Study of Respiratory-gated Positron Emission Tomography Acquisitions of the Liver (NCT NCT01219985)
NCT ID: NCT01219985
Last Updated: 2016-05-27
Results Overview
Observers have to analyse Ungated and/or CT-based PET images. They have to report, for each uptake they see, the corresponding liver segment (according to Couinaud segmental classification).
COMPLETED
NA
50 participants
day 1
2016-05-27
Participant Flow
Participant milestones
| Measure |
Investigation Arm
Patients definitely included in the trial. All these patients underwent non-gated and gated PET/CT as well as hepatic surgery. In addition, histological analysis of the resected lesions were also obtained.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Investigation Arm
Patients definitely included in the trial. All these patients underwent non-gated and gated PET/CT as well as hepatic surgery. In addition, histological analysis of the resected lesions were also obtained.
|
|---|---|
|
Overall Study
Physician Decision
|
20
|
Baseline Characteristics
Benefits Study of Respiratory-gated Positron Emission Tomography Acquisitions of the Liver
Baseline characteristics by cohort
| Measure |
Investigation Arm
n=50 Participants
Patients included in the trial. n=50
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 1Population: Patients who underwent liver resection
Observers have to analyse Ungated and/or CT-based PET images. They have to report, for each uptake they see, the corresponding liver segment (according to Couinaud segmental classification).
Outcome measures
| Measure |
Ungated Per-lesion Sensitivity
n=30 Participants
Ungated PET images results were compared with pathological analyses
|
CT-Based Per-lesion Sensitivity
n=30 Participants
CT-Based PET images results were compared with pathological analyses
|
|---|---|---|
|
Number of Detected Uptakes on PET Images
Number of lesions on PET images
|
47 number of real metastatic lesions
|
54 number of real metastatic lesions
|
|
Number of Detected Uptakes on PET Images
Number of lesions found by pathological analysis
|
74 number of real metastatic lesions
|
74 number of real metastatic lesions
|
SECONDARY outcome
Timeframe: Day 1Population: The number of participant has been determined on the basis of the annual possible recruitment in the institution to keep the study feasible.
For each detected uptake (in Ungated or CT-based PET images), observers have to report the corresponding maximum standardized uptake value (SUVmax). The SUVmax was obtained automatically in a volume of interest encompassing the entire lesion.
Outcome measures
| Measure |
Ungated Per-lesion Sensitivity
n=30 Participants
Ungated PET images results were compared with pathological analyses
|
CT-Based Per-lesion Sensitivity
CT-Based PET images results were compared with pathological analyses
|
|---|---|---|
|
Lesions Uptake Measurement (SUVmax)
Ungated
|
7.6 g/L
Standard Deviation 3.1
|
—
|
|
Lesions Uptake Measurement (SUVmax)
CT-Based
|
8.5 g/L
Standard Deviation 3.5
|
—
|
Adverse Events
Investigation Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Pr. Marc-Etienne Meyer
Centre Hospital-Universitaire d'Amiens
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place