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

March 8, 2022 updated by: Institut Bergonié

Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bayonne, France, 64100
        • Centre Hospitalier de la Côte Basque
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Pessac, France, 33604
        • Hopital Haut Lévêque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: computed tomography
Procedure: positron emission tomography
Procedure: radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of True Positive Plus True Negative Patients
Time Frame: 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).
3 months after RFA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of True Positive Patients
Time Frame: 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)
3 months after RFA
Percentage of True Negative Patients
Time Frame: 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)
3 months after RFA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Study Chair: Francoise Bonichon, MD, Institut Bergonie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 26, 2006

First Submitted That Met QC Criteria

September 26, 2006

First Posted (Estimate)

September 28, 2006

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000510046
  • IB-2005-30
  • INCA-RECF0142
  • IB-TEP-ARF-MPs-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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