PET Scan and CT Scan in Evaluating Response in Patients Undergoing Radiofrequency Ablation for Lung Metastases

NCT00382252 | Completed Results

• 4 other identifiers: CDR0000510046IB-2005-30INCA-RECF0142IB-TEP-ARF-MPs-05
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 3

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.

Conditions

Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; lung metastases

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months after RFA

Secondary Outcomes (2)

• Percentage of True Positive Patients

  3 months after RFA

• Percentage of True Negative Patients

  3 months after RFA

Study Arms (1)

18F-FDG PET/CT + RFA

EXPERIMENTAL

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.

Procedure: computed tomography; Procedure: positron emission tomography; Procedure: radiofrequency ablation

Interventions

computed tomography PROCEDURE

18F-FDG PET/CT + RFA

positron emission tomography PROCEDURE

18F-FDG PET/CT + RFA

radiofrequency ablation PROCEDURE

18F-FDG PET/CT + RFA

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (3)

Centre Hospitalier de la Cote Basque

Bayonne, 64100, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Related Publications (1)

• Bonichon F, Palussiere J, Godbert Y, Pulido M, Descat E, Devillers A, Meunier C, Leboulleux S, de Baere T, Galy-Lacour C, Lagoarde-Segot L, Cazeau AL. Diagnostic accuracy of 18F-FDG PET/CT for assessing response to radiofrequency ablation treatment in lung metastases: a multicentre prospective study. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1817-27. doi: 10.1007/s00259-013-2521-9. Epub 2013 Sep 17.

  PMID: 24042540 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Magnetic Resonance Spectroscopy; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr Françoise Bonichon
• Organization: Institut Bergonie

F.Bonichon@bordeaux.unicancer.fr

Study Officials

• Francoise Bonichon, MD

  Institut Bergonié

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: May 2, 2005
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2011
• Last Updated: March 9, 2022
• Results First Posted: March 9, 2022

Record last verified: 2022-03

Locations

FR (3)