Trial Outcomes & Findings for PET Scan and CT Scan in Evaluating Response in Patients Undergoing Radiofrequency Ablation for Lung Metastases (NCT NCT00382252)

Results Overview

Accuracy of PET/CT scan to determine response of patients at 3 months will be assessed and compared with standard biopsy 3 months after RFA ,if performed or follow-up at 12 months. Number of patients with true positive results plus number of patients with true negative results divided by the number of evaluable patients (accuracy).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

89 participants

Primary outcome timeframe

3 months after RFA

Results posted on

2022-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	18F-FDG PET/CT + RFA 18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA. RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes. CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA. computed tomography positron emission tomography radiofrequency ablation
Overall Study STARTED	89
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	18F-FDG PET/CT + RFA 18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA. RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes. CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA. computed tomography positron emission tomography radiofrequency ablation
Overall Study Death	4
Overall Study Protocol Violation	8
Overall Study Not treated by RFA	1

Baseline Characteristics

2 patients for whom sex was not available

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	18F-FDG PET/CT + RFA n=89 Participants 18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA. RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes. CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA. computed tomography positron emission tomography radiofrequency ablation
Age, Continuous	65 years STANDARD_DEVIATION 11.2 • n=89 Participants
Sex: Female, Male Female	41 Participants n=87 Participants • 2 patients for whom sex was not available
Sex: Female, Male Male	46 Participants n=87 Participants • 2 patients for whom sex was not available
Region of Enrollment France	89 participants n=89 Participants

PRIMARY outcome

Timeframe: 3 months after RFA

Accuracy of PET/CT scan to determine response of patients at 3 months will be assessed and compared with standard biopsy 3 months after RFA ,if performed or follow-up at 12 months. Number of patients with true positive results plus number of patients with true negative results divided by the number of evaluable patients (accuracy).

Outcome measures

Outcome measures
Measure	18F-FDG PET/CT + RFA n=76 Participants 18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA. RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes. CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA. computed tomography positron emission tomography radiofrequency ablation
Percentage of True Positive Plus True Negative Patients	40.79 percentage of participants Interval 29.65 to 52.67

SECONDARY outcome

Timeframe: 3 months after RFA

Sensitivity of PET/CT scan to determine response of patients at 3 months will be assessed and compared with standard biopsy 3 months after RFA ,if performed or follow-up at 12 months. Number of patients with true positive results divided by the number of patients with true positive plus false negative results (sensitivity)

Outcome measures

Outcome measures
Measure	18F-FDG PET/CT + RFA n=76 Participants 18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA. RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes. CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA. computed tomography positron emission tomography radiofrequency ablation
Percentage of True Positive Patients	100 percentage of participants Interval 69.15 to 100.0

SECONDARY outcome

Timeframe: 3 months after RFA

Specificity of PET/CT scan to determine response of patients at 3 months will be assessed and compared with standard biopsy 3 months after RFA ,if performed or follow-up at 12 months. Number of patients with true negative results divided by the number of patients with true negative plus false positive results (specificity)

Outcome measures

Outcome measures
Measure	18F-FDG PET/CT + RFA n=76 Participants 18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA. RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes. CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA. computed tomography positron emission tomography radiofrequency ablation
Percentage of True Negative Patients	31.82 percentage of participants Interval 20.89 to 44.44

Adverse Events

18F-FDG PET/CT + RFA

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	18F-FDG PET/CT + RFA n=89 participants at risk 18F-FDG PET/CT: I.V. injection of 5 to 15 mCi (185 to 555 MBq) of 18F-FDG. Capture time of 60 to 90 minutes. Acquisition of images: A whole body CT scan with normal breathing will be performed for attenuation correction with 5mm thick slices. A whole body PET acquisition of 6 or 7 steps will be done from the upper third of the thighs to the base of the skull. PETC/CT performed at inclusion, 1 month et 3 months after RFA. RFA: Treatment procedure: the location under scanner allows to place the electrode in the center of the tumor. The treatment then lasts 15 to 20 minutes. CT scanner: The CT examination will be performed in spiral acquisition without or after injection of contrast medium (70 ml at 2 or 3 ml/sec). On a 16-slice scanner, the examination is performed with 1.25 mm slices every 0.9. Constants generally used 120kV, 350 mA. Ct scanner performed at inclusion, 48H post-RFA, 1 month, 3 months, 6, 9 and 12 months after RFA. computed tomography positron emission tomography radiofrequency ablation
Respiratory, thoracic and mediastinal disorders Dyspnea	1.1% 1/89 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
General disorders Disease progression	1.1% 1/89 • Number of events 1 Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.

Other adverse events

Adverse event data not reported

Additional Information

Dr Françoise Bonichon

Institut Bergonie

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place