Metastatic CancerTEPARFNCT00382252
PET Scan and CT Scan in Evaluating Response in Patients Undergoing Radiofrequency Ablation for Lung Metastases
A study testing computed tomography, positron emission tomography and radiofrequency ablation in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Institut Bergonié at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- computed tomography, positron emission tomography and radiofrequency ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 3 sitesFrance
- Study dates
- 2 May 2005to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier de la Cote Basque
Bayonne, 64100
Institut Bergonie
Bordeaux, 33076
Hopital Haut Leveque
Pessac, 33604
About this study
Official title: 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.
Read the 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.
- Being tested
- computed tomography, positron emission tomography, radiofrequency ablation
- Keywords
- unspecified adult solid tumor, protocol specific, lung metastases
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyProcedure or surgery
positron emission tomographyProcedure or surgery
radiofrequency ablationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: computed tomography; Procedure: positron emission tomography; Procedure: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months after RFA
Secondary outcomes (2)
Percentage of True Positive Patients
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)
Measured: 3 months after RFA
Percentage of True Negative Patients
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)
Measured: 3 months after RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study start2 May 2005
- Primary completionDec 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francoise Bonichon, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382252
- Sponsor's protocol ID
- CDR0000510046
- Other IDs
- IB-2005-30, INCA-RECF0142, IB-TEP-ARF-MPs-05
- Acronym
- TEPARF
- Status last verified
- Mar 2022
- First submitted
- 26 Sep 2006
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24042540
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Positron Emission Tomography/CT Scan for Response Evaluation After Radiofrequency Ablation in Patients With Lung Metastases
- ClinicalTrials.gov ID
- NCT00382252
- Acronym / sponsor ID
- TEPARF / CDR0000510046
- Keywords
- unspecified adult solid tumor, protocol specific, lung metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 2 May 2005 (actual)
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Posted 9 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG PET/CT + RFA | Experimental | Procedure: computed tomography, Procedure: positron emission tomography, Procedure: radiofrequency ablation18F-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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomography | Procedure or surgery | 18F-FDG PET/CT + RFA |
| positron emission tomography | Procedure or surgery | 18F-FDG PET/CT + RFA |
| radiofrequency ablation | Procedure or surgery | 18F-FDG PET/CT + RFA |
Primary outcome
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).
2 secondary outcomes
Percentage of True Positive Patients
Time frame: 3 months after RFA
Percentage of True Negative Patients
Time frame: 3 months after RFA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24042540Bonichon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francoise Bonichon, MD study chair
Institut Bergonié
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography, positron emission tomography and radiofrequency ablation in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Institut Bergonié at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of True Positive Plus True Negative Patients (time frame: 3 months after RFA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00382252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.