Neoplasms, BenignPhase 2NCT00868647
Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood
A Phase 2 study testing Radiofrequency ablation (RFA) in people with Neoplasms, Benign and Neoplasms, Malignant, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
This is a single-center, Phase II study including only patients on whom a decision to conduct radiofrequency ablation (RFA) has already been made. The primary objective of this study assess if quality of life was improved by RFA as assessed at baseline, 3 and potentially 6 and 12 months following RFA for the benign… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms, Benign, Neoplasms, Malignant
- What is being tested?
- Radiofrequency ablation (RFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lesion acquired in childhood (at <21 years of age)
- Any lesion location except CNS
- Any malignant tumor or metastasis
- Any benign lesion (e.g. desmoids, venous or lymphatic vascular anomalies, aneurysmal bone cysts, osteoid osteoma, tongue hypertrophy, or painful neuropathy)
- Patients with malignant disease have had histologic confirmation of disease at initial diagnosis.
- ≥ 90 day life expectancy
Show all 9Show fewer
- Potential benefit of RFA outweighs risk as determined by PI
- Other local tumor control measures are not recommended for malignant lesion based on review in multidisciplinary team conference or the patient refuses recommended local tumor control measures
- The patient is not expected to become short of breath at rest after RFA (forced vital capacity ≥33% of normal by pulmonary function tests) if pulmonary RFA is considered
Who cannot join
- Patients with uncontrolled infection.
- Patients with co-morbidities affecting inclusion criteria above.
- Patients who are pregnant and/or breastfeeding.
- Patients who had a change in chemotherapy within one month before RFA
- Patients who have planned change in chemotherapy and/or radiation therapy (to same site as RFA) interventions within the first three months following RFA.
- Patients should not be considered for pulmonary RFA if they have poorly compliant lungs (recently required mechanical ventilation) or require supplemental oxygen.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood: A Phase II Study
This is a single-center, Phase II study including only patients on whom a decision to conduct radiofrequency ablation (RFA) has already been made. The primary objective of this study assess if quality of life was improved by RFA as assessed at baseline, 3 and potentially 6 and 12 months following RFA for the benign lesions.
RFA is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using an electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.
Read more
RF ablation is an alternative for local tumor control when other treatments (surgery, radiotherapy or chemotherapy) are not feasible (less effective or at higher risk). Thermal ablation at times is the only remaining alternative for patient cure, prolonged survival or palliation. Cryotherapy, and microwave, laser and focused ultrasound are alternative thermal ablation techniques used in adults but there has been no experience in children with these alternative methods.
To be eligible for this study, patients must have acquired lesions at < 21 years of age (central nervous system lesions are excluded from this study). Study participants will have the RFA procedure performed at Seattle Children's and will have follow-up evaluations at various time points post-RFA.
- Conditions
- Neoplasms, Benign, Neoplasms, Malignant
- Being tested
- Radiofrequency ablation (RFA)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation (RFA)Procedure or surgery
Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation | Other | Not described Receives: Procedure: Radiofrequency ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess if quality of life was improved by RFA for the benign lesions
Measured: baseline, 3 months and potentially 6 and 12 months following RFA
Secondary outcomes (8)
Assess the response to RF ablative therapy by pain relief from painful benign or malignant lesions.
Measured: baseline, 3 months and potentially 6 and 12 months following RFA
Evaluate the rate of short-term ablation of benign lesions produced by RFA
Measured: baseline, 3 months and potentially 6 and 12 months following RFA
Assess toxicity related to all RFA procedures using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: within 3 months (potentially 6-12 months) following RFA
Assess the response to RFA by malignant tumor markers (e.g. AFP)
Measured: 1, 3, 6, and 12 months following RFA
Assess if quality of life was improved by RFA for patients with malignant lesions
Measured: baseline, 3, 6 and 12 months
Evaluate the proportion of malignant lesions that show short-term ablation produced by RFA.
Measured: 3 months post Radiofrequency Ablation (RFA), as compared to 1 month post RFA imaging
Determine the rate of durable ablation in malignant lesions that achieve short-term ablation by RFA
Measured: 12 months post RFA
Assess the time to malignant tumor progression (as defined by RECIST) of lesions treated with RFA
Measured: 1, 3, 6, and 12 months post RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startJun 2007
- Primary completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, BenignStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Fredric A Hoffer, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868647
- Sponsor's protocol ID
- RFAII
- Status last verified
- Aug 2009
- First submitted
- 23 Mar 2009
- Last updated
- 1 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation (RFA) Of Tumors Acquired In Childhood: A Phase II Study
- ClinicalTrials.gov ID
- NCT00868647
- Acronym / sponsor ID
- RFAII
- Conditions
- Neoplasms, Benign, Neoplasms, Malignant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2012 (estimated)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, Phase II study including only patients on whom a decision to conduct radiofrequency ablation (RFA) has already been made. The primary objective of this study assess if quality of life was improved by RFA as assessed at baseline, 3 and potentially 6 and 12 months following RFA for the benign lesions.
RFA is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using an electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.
RF ablation is an alternative for local tumor control when other treatments (surgery, radiotherapy or chemotherapy) are not feasible (less effective or at higher risk). Thermal ablation at times is the only remaining alternative for patient cure, prolonged survival or palliation. Cryotherapy, and microwave, laser and focused ultrasound are alternative thermal ablation techniques used in adults but there has been no experience in children with these alternative methods.
To be eligible for this study, patients must have acquired lesions at < 21 years of age (central nervous system lesions are excluded from this study). Study participants will have the RFA procedure performed at Seattle Children's and will have follow-up evaluations at various time points post-RFA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation | Other | Procedure: Radiofrequency ablation (RFA) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Lesion acquired in childhood (at <21 years of age)
- Any lesion location except CNS
- Any malignant tumor or metastasis
- Any benign lesion (e.g. desmoids, venous or lymphatic vascular anomalies, aneurysmal bone cysts, osteoid osteoma, tongue hypertrophy, or painful neuropathy)
- Patients with malignant disease have had histologic confirmation of disease at initial diagnosis.
Key exclusion criteria (6 listed)
- Patients with uncontrolled infection.
- Patients with co-morbidities affecting inclusion criteria above.
- Patients who are pregnant and/or breastfeeding.
- Patients who had a change in chemotherapy within one month before RFA
- Patients who have planned change in chemotherapy and/or radiation therapy (to same site as RFA) interventions within the first three months following RFA.
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 |
|---|---|---|
| Radiofrequency ablation (RFA)Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death. | Procedure or surgery | Radiofrequency Ablation |
Primary outcome
Assess if quality of life was improved by RFA for the benign lesions
Time frame: baseline, 3 months and potentially 6 and 12 months following RFA
8 secondary outcomes
Assess the response to RF ablative therapy by pain relief from painful benign or malignant lesions.
Time frame: baseline, 3 months and potentially 6 and 12 months following RFA
Evaluate the rate of short-term ablation of benign lesions produced by RFA
Time frame: baseline, 3 months and potentially 6 and 12 months following RFA
Assess toxicity related to all RFA procedures using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time frame: within 3 months (potentially 6-12 months) following RFA
Assess the response to RFA by malignant tumor markers (e.g. AFP)
Time frame: 1, 3, 6, and 12 months following RFA
Assess if quality of life was improved by RFA for patients with malignant lesions
Time frame: baseline, 3, 6 and 12 months
Evaluate the proportion of malignant lesions that show short-term ablation produced by RFA.
Time frame: 3 months post Radiofrequency Ablation (RFA), as compared to 1 month post RFA imaging
Determine the rate of durable ablation in malignant lesions that achieve short-term ablation by RFA
Time frame: 12 months post RFA
Assess the time to malignant tumor progression (as defined by RECIST) of lesions treated with RFA
Time frame: 1, 3, 6, and 12 months post RFA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2009.
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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.
Fredric A Hoffer, MD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiofrequency ablation (RFA) in people with Neoplasms, Benign and Neoplasms, Malignant, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. 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: paused, as of the sponsor's last update on 1 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Assess if quality of life was improved by RFA for the benign lesions (time frame: baseline, 3 months and potentially 6 and 12 months following RFA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2009.