Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases
18 Years
N/A
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Accuracy of positron emission tomography (PET) and CT scan in measuring response at 3 months after radiofrequency ablation (RFA)
Safety Issue:
No
Principal Investigator
Francoise Bonichon, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Bergonié
Authority:
United States: Federal Government
Study ID:
CDR0000510046
NCT ID:
NCT00382252
Start Date:
September 2005
Completion Date:
Related Keywords:
- Metastatic Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- lung metastases
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Lung Neoplasms
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