Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific, lung metastases
Brief summary
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Diagnostic procedures, such as PET scan and CT scan, may help doctors measure the patient's response to treatment. PURPOSE: This clinical trial is studying PET scan and CT scan to see how well they work in evaluating response to treatment in patients undergoing radiofrequency ablation for lung metastases.
Detailed description
OBJECTIVES: Primary * Determine the accuracy of positron emission tomography (PET) and CT scan in measuring response at 3 months after radiofrequency ablation (RFA) in patients with lung metastases. Secondary * Determine the agreement between observers analyzing PET/CT scan results. * Determine the outcome of these patients. * Determine the false-positive rate and false-negative rate of PET/CT scan at 1 and 3 months in these patients. * Determine the optimal time for obtaining a negative PET scan. * Determine the sensitivity, specificity, positive predictive value, and negative predictive value of PET/CT scan at 1 and 3 months. * Determine the morbidity associated with RFA. * Determine the disease-free survival after RFA and the factors predicting recurrent disease in these patients. OUTLINE: This is a multicenter study. Patients undergo positron emission tomography (PET) and CT scan at baseline. Patients then undergo radiofrequency ablation (RFA) for lung metastases. PET/CT scan is repeated at 1 week, 1 month, and 3 months after RFA. After completion of RFA, patients are followed by clinical examination and conventional scanning at 6, 9, and 12 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Interventions
PROCEDUREcomputed tomography
PROCEDUREpositron emission tomography
PROCEDUREradiofrequency ablation
Sponsors
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed cancer * Radiologically suspected pulmonary metastases * May be confirmed histologically or by specific markers * Less than 6 lesions * Lesions \< 40 mm * Prior positron emission tomography shows 1 hyperfixation (standard uptake variable \> 3) at the level of lesions to be treated * Lesions must not be attached to or next to major mediastinal structures * Radiofrequency ablation planned as treatment PATIENT CHARACTERISTICS: * Life expectancy \> 6 months * No uncontrolled medical condition, including any of the following: * Psychiatric condition * Infection * Coronary insufficiency * New York Heart Association class III-IV heart disease * No other serious condition * No contraindication to general anesthesia * Not pregnant or nursing PRIOR CONCURRENT THERAPY: * At least 30 days since prior participation in an investigational study * At least 30 days since prior chemotherapy * No other concurrent investigational agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of True Positive Plus True Negative Patients | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of True Positive Patients | 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) |
| Percentage of True Negative Patients | 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) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 89 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Not treated by RFA | 1 |
| Overall Study | Protocol Violation | 8 |
Baseline characteristics
| Characteristic | 18F-FDG PET/CT + RFA |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment France | 89 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 2 / 89 |
Outcome results
Primary
Percentage of True Positive Plus True Negative Patients
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).
Time frame: 3 months after RFA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-FDG PET/CT + RFA | Percentage of True Positive Plus True Negative Patients | 40.79 percentage of participants |
Secondary
Percentage of True Negative Patients
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)
Time frame: 3 months after RFA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-FDG PET/CT + RFA | Percentage of True Negative Patients | 31.82 percentage of participants |
Secondary
Percentage of True Positive Patients
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)
Time frame: 3 months after RFA
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 18F-FDG PET/CT + RFA | Percentage of True Positive Patients | 100 percentage of participants |