PET Scan and CT Scan in Evaluating Response in Patients Undergoing Radiofrequency Ablation for Lung Metastases - Full Text View

Sponsored by:	Institut Bergonie
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00382252

Purpose

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.

Condition	Intervention
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific	Procedure: computed tomography Procedure: positron emission tomography Procedure: radiofrequency ablation

MedlinePlus related topics: CT Scans Cancer Nuclear Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Accuracy of positron emission tomography (PET) and CT scan in measuring response at 3 months after radiofrequency ablation (RFA) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sensitivity, specificity, false-positive rate, and false-negative rate of PET/CT scan [ Designated as safety issue: No ]
Morbidity associated with RFA [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	September 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382252

Locations

France
Centre Hospitalier de la Cote Basque	Recruiting
Bayonne, France, 64100
Contact: Denis Arnaud, MD 33-5-5944-3535
Hopital Haut Leveque	Recruiting
Pessac, France, 33604
Contact: Oliver Corneloup, MD 33-5-5765-6565
Institut Bergonie	Recruiting
Bordeaux, France, 33076
Contact: Francoise Bonichon, MD 33-556-333-321

Sponsors and Collaborators

Institut Bergonie

Investigators

Study Chair:

Francoise Bonichon, MD

Institut Bergonie

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000510046, IB-2005-30, INCA-RECF0142, IB-TEP-ARF-MPs-05
Study First Received:	September 26, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00382252 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific
lung metastases

Study placed in the following topic categories:

Neoplasm Metastasis

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasm Metastasis

ClinicalTrials.gov processed this record on May 07, 2009