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

• Sponsor: Institut Bergonié (Other)
• Overall Status: Completed
• CT.gov ID: NCT00382252
• Collaborator: (none)
• Enrollment: 89
• Locations: 3
• Arm: 1
• Actual Duration (Months): 72
• Patients Per Site: 29.7
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Procedure: computed tomography; Procedure: positron emission tomography; Procedure: radiofrequency ablation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases
• Actual Study Start Date: May 2, 2005
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier de la Cote Basque	Bayonne		France	64100
2	Institut Bergonie	Bordeaux		France	33076
3	Hopital Haut Leveque	Pessac		France	33604

Sponsors and Collaborators

• Institut Bergonié

Investigators

• Study Chair: Francoise Bonichon, MD, Institut Bergonié

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Bergonié
• ClinicalTrials.gov Identifier: NCT00382252
• Other Study ID Numbers: CDR0000510046; IB-2005-30; INCA-RECF0142; IB-TEP-ARF-MPs-05
• First Posted: Sep 28, 2006
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institut Bergonié: unspecified adult solid tumor, protocol specific; lung metastases
• Additional relevant MeSH terms: Neoplasm Metastasis

Study Results

Participant Flow

Arm/Group Title	18F-FDG PET/CT + RFA
Arm/Group Description	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
Period Title: Overall Study
STARTED	89
COMPLETED	76
NOT COMPLETED	13

Baseline Characteristics

Arm/Group Title	18F-FDG PET/CT + RFA
Arm/Group Description	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
Overall Participants	89
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65 (11.2)
Sex: Female, Male (Count of Participants)
Female	41 46.1%
Male	46 51.7%
Region of Enrollment (participants) [Number]
France	89 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of True Positive Plus True Negative Patients
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-FDG PET/CT + RFA
Arm/Group Description	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
Measure Participants	76
Number (95% Confidence Interval) [percentage of participants]	40.79 45.8%

2. Secondary Outcome

Title	Percentage of True Positive Patients
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-FDG PET/CT + RFA
Arm/Group Description	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
Measure Participants	76
Number (95% Confidence Interval) [percentage of participants]	100 112.4%

3. Secondary Outcome

Title	Percentage of True Negative Patients
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	18F-FDG PET/CT + RFA
Arm/Group Description	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
Measure Participants	76
Number (95% Confidence Interval) [percentage of participants]	31.82 35.8%

Adverse Events

Adverse Event Reporting Description	Only serious adverse events were monitored. Adverse events (non-serious) were not assessed/monitored during the study.
Arm/Group Title	18F-FDG PET/CT + RFA
Arm/Group Description	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
All Cause Mortality
	18F-FDG PET/CT + RFA
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	18F-FDG PET/CT + RFA
	Affected / at Risk (%)	# Events
Total	2/89 (2.2%)
General disorders
Disease progression	1/89 (1.1%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/89 (1.1%)	1
Other (Not Including Serious) Adverse Events
	18F-FDG PET/CT + RFA
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.