Soft Tissue NeoplasmsNCT00041886
Radiofrequency Ablation of Painful Soft Tissue Neoplasms
An observational study of Soft Tissue Neoplasms, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Radiofrequency ablation is used to treat patients with many different conditions. It is used to treat heart arrhythmia and benign bone tumors, and to control bleeding during surgery. It has been approved by the Food and Drug Administration for soft tissue ablation (removal). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Neoplasms
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jun 2005
- Phase
- Observational
- 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
- All patients must have pain poorly controlled by conventional methods, defined as ongoing pain despite maximum pharmacologic interventions, or severe side effects like mental status alteration from medication, as determined by the patient along with the palliative care/ pain consult service and/or the patient's physician.
- Persistent or recalcitrant pain will be localized to a specific neoplastic lesion determined by consensus review by the P.I. with the pain/palliative care service, the patient's physician, and the diagnostic radiologist reviewing the case. Only patients with a limited number of lesions causing pain will be enrolled, and only if there is a target lesion which can be the focus of ablation.
- All patients must have had a diagnostic CT scan which conclusively reveal a soft tissue metastasis, which is the source of pain as determined by the Palliative care oncologist. One independent radiologist who is not a co-investigator in this study must confirm this. Tumor does not have to be completely destroyable by RFA, as patients may benefit from simple debulking, denervation, or decrease in intratumoral pressure.
- Age greater than or equal to 18 years.
- Biopsy of lesion in question for histologic or cytologic confirmation of cancer will be obtained when safe and clinically indicated, or if there is reasonable doubt as to diagnosis. Reasonable doubt will be determined by the PI, the surgeon, and the palliative care oncologist by consensus.
- Performance Status ECOG 0-2.
Show all 13Show fewer
- Life expectancy of 3 months or greater.
- Platelet count greater than 50,000/mL, absolute granulocyte count (AGC) greater than 1,000/mL, serum creatine less than 1.5 mg/dl (or if greater than 1.5, measured creatine clearance greater than 50mL/min). Any patient with elevated PTT or PT that is uncorrectable will be evaluated by NIH hematology for safety of procedure. This will allow patients with "falsely-elevated" values to undergo the same evaluation that they would have for surgery or other invasive procedure. Dr. Horne is the hematologist and coinvestigator on this protocol.
- No serious concurrent medical illness.
- Bi-dimensionally measurable disease by radiographic means or physical examination.
- The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question will be reviewed by the ethics committee.
- Consult with an NCI surgeon and Palliative care oncologist who will determine if the patient's pain medications and other options (surgical) have been optimized prior to entry in this protocol. Surgical options must be either not possible, or rejected by the patient. Surgery will be either offered or ruled out as an alternative by the NCI surgeon prior to treatment.
- Chemotherapy, radiation therapy, and classification of drug therapy must be stable without changes for 2 weeks prior to tumor ablation.
Who cannot join
- Patients with a coagulopathy which cannot be corrected, or a bleeding diathesis, will be excluded from this study. Patients taking anti-inflammatory agents or aspirin, heparin, heparinoids, or coumadin will be excluded until the prothrombin time and partial thromboplastin time have normalized.
- Patients with an altered mental status that precludes understanding or consenting for a procedure will be excluded from this study.
- Pregnant or nursing women and women of childbearing potential unless using effective contraception as determined by the patient's physician.
- Patients who are poor medical risk because of other non malignant systemic disease or active, uncontrolled infection.
- Patients should not change the class of pain medication for two weeks prior to treatment and are ineligible if class is changed within two weeks prior. If the class of pain medication is switched within two weeks after treatment, the patient becomes inevaluable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Radiofrequency ablation is used to treat patients with many different conditions. It is used to treat heart arrhythmia and benign bone tumors, and to control bleeding during surgery. It has been approved by the Food and Drug Administration for soft tissue ablation (removal). The technique involves inserting a probe, guided by computed tomography or ultrasound, and sending radio waves through the probe. The radio waves generate heat, which both destroys adjacent tissue and cauterizes blood vessels.
This study will enroll 15 adults (age 18 or older) with soft tissue metastases who suffer pain that is not well controlled by other means, such as drugs. The goal is to reduce their pain or their use of analgesics by partially destroying some of their tumors.
Read more
Patients will be ineligible for the study if they change the class of pain medication they use within 2 weeks before or 2 weeks after the study treatment. Patients will fill out short questionnaires about pain and daily activities (Brief Pain Inventory) before treatment and 1 day, 1 week, 1 month, 3 months, and 12 months after treatment to ascertain whether their pain is better controlled with less pain medication.
For the treatment, most patients will receive local anesthetic in the area where the probe is inserted. Some patients may require general anesthesia. The probe will remain in place typically for 10 to 30 minutes. For larger tumors, it may be inserted at different positions.
Read the detailed description
This study will examine the efficacy of using radiofrequency ablation (RFA) to treat pain soft tissue metastases not well controlled by conventional methods of treatment, defined as ongoing pain despite maximum pharmacologic interventions, or severe side effects like mental status alteration from medication. Prior experience with similar techniques in the liver, kidney, heart, bones, prostate, lymph nodes, brain, pancreas, and nerve ganglions has found that ablation of a specific volume of tissue with the application of RFA energy is safe and effective. We are hopeful that this method of tissue ablation could assist in the difficult management of patients with painful lesions. The goal will be to reduce pain, or to reduce use of analgesics. Any decrease in strength of opiate used, or in dose equivalent same-medication on a per week basis will be considered significant.
- Conditions
- Soft Tissue Neoplasms
- Keywords
- Minimally Invasive Surgery, Percutaneous, Radiofrequency Ablation, Soft Tissue Metastases, Thermal Ablation, Soft Tissue Neoplasm, Tumor
- Medical subject headings
- Soft Tissue Neoplasms, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2002 (estimated)
- Study startJul 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue NeoplasmsStudies 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
- Observational
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041886
- Sponsor's protocol ID
- 020244
- Other IDs
- 02-CC-0244
- Status last verified
- Jun 2005
- First submitted
- 18 Jul 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Wood BJ, Ramkaransingh JR, Fojo T, Walther MM, Libutti SK. Percutaneous tumor ablation with radiofrequency. Cancer. 2002 Jan 15;94(2):443-51. doi: 10.1002/cncr.10234.
PubMed 11900230Dupuy DE, Goldberg SN. Image-guided radiofrequency tumor ablation: challenges and opportunities--part II. J Vasc Interv Radiol. 2001 Oct;12(10):1135-48. doi: 10.1016/s1051-0443(07)61670-4. No abstract available.
PubMed 11585879Wood BJ. Feasibility of thermal ablation of lytic vertebral metastases with radiofrequency current. Cancer J. 2002 Jan-Feb;8(1):26-8; discussion 28-9. doi: 10.1097/00130404-200201000-00004. No abstract available.
PubMed 11895200
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation of Painful Soft Tissue Neoplasms
- ClinicalTrials.gov ID
- NCT00041886
- Acronym / sponsor ID
- 020244
- Conditions
- Soft Tissue Neoplasms
- Keywords
- Minimally Invasive Surgery, Percutaneous, Radiofrequency Ablation, Soft Tissue Metastases, Thermal Ablation, Soft Tissue Neoplasm, Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Jul 2002
- Study completion
- Jun 2005
- First posted
- 19 Jul 2002 (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.
Radiofrequency ablation is used to treat patients with many different conditions. It is used to treat heart arrhythmia and benign bone tumors, and to control bleeding during surgery. It has been approved by the Food and Drug Administration for soft tissue ablation (removal). The technique involves inserting a probe, guided by computed tomography or ultrasound, and sending radio waves through the probe. The radio waves generate heat, which both destroys adjacent tissue and cauterizes blood vessels.
This study will enroll 15 adults (age 18 or older) with soft tissue metastases who suffer pain that is not well controlled by other means, such as drugs. The goal is to reduce their pain or their use of analgesics by partially destroying some of their tumors.
Patients will be ineligible for the study if they change the class of pain medication they use within 2 weeks before or 2 weeks after the study treatment. Patients will fill out short questionnaires about pain and daily activities (Brief Pain Inventory) before treatment and 1 day, 1 week, 1 month, 3 months, and 12 months after treatment to ascertain whether their pain is better controlled with less pain medication.
For the treatment, most patients will receive local anesthetic in the area where the probe is inserted. Some patients may require general anesthesia. The probe will remain in place typically for 10 to 30 minutes. For larger tumors, it may be inserted at different positions.
Detailed description
This study will examine the efficacy of using radiofrequency ablation (RFA) to treat pain soft tissue metastases not well controlled by conventional methods of treatment, defined as ongoing pain despite maximum pharmacologic interventions, or severe side effects like mental status alteration from medication. Prior experience with similar techniques in the liver, kidney, heart, bones, prostate, lymph nodes, brain, pancreas, and nerve ganglions has found that ablation of a specific volume of tissue with the application of RFA energy is safe and effective. We are hopeful that this method of tissue ablation could assist in the difficult management of patients with painful lesions. The goal will be to reduce pain, or to reduce use of analgesics. Any decrease in strength of opiate used, or in dose equivalent same-medication on a per week basis will be considered significant.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- All patients must have pain poorly controlled by conventional methods, defined as ongoing pain despite maximum pharmacologic interventions, or severe side effects like mental status alteration from medication, as determined by the patient along with the palliative care/ pain consult service and/or the patient's physician.
- Persistent or recalcitrant pain will be localized to a specific neoplastic lesion determined by consensus review by the P.I. with the pain/palliative care service, the patient's physician, and the diagnostic radiologist reviewing the case. Only patients with a limited number of lesions causing pain will be enrolled, and only if there is a target lesion which can be the focus of ablation.
- All patients must have had a diagnostic CT scan which conclusively reveal a soft tissue metastasis, which is the source of pain as determined by the Palliative care oncologist. One independent radiologist who is not a co-investigator in this study must confirm this. Tumor does not have to be completely destroyable by RFA, as patients may benefit from simple debulking, denervation, or decrease in intratumoral pressure.
- Age greater than or equal to 18 years.
- Biopsy of lesion in question for histologic or cytologic confirmation of cancer will be obtained when safe and clinically indicated, or if there is reasonable doubt as to diagnosis. Reasonable doubt will be determined by the PI, the surgeon, and the palliative care oncologist by consensus.
Key exclusion criteria (5 listed)
- Patients with a coagulopathy which cannot be corrected, or a bleeding diathesis, will be excluded from this study. Patients taking anti-inflammatory agents or aspirin, heparin, heparinoids, or coumadin will be excluded until the prothrombin time and partial thromboplastin time have normalized.
- Patients with an altered mental status that precludes understanding or consenting for a procedure will be excluded from this study.
- Pregnant or nursing women and women of childbearing potential unless using effective contraception as determined by the patient's physician.
- Patients who are poor medical risk because of other non malignant systemic disease or active, uncontrolled infection.
- Patients should not change the class of pain medication for two weeks prior to treatment and are ineligible if class is changed within two weeks prior. If the class of pain medication is switched within two weeks after treatment, the patient becomes inevaluable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 11900230Wood BJ, Ramkaransingh JR, Fojo T, Walther MM, Libutti SK. Percutaneous tumor ablation with radiofrequency. Cancer. 2002 Jan 15;94(2):443-51. doi: 10.1002/cncr.10234.
- Background: PubMed 11585879Dupuy DE, Goldberg SN. Image-guided radiofrequency tumor ablation: challenges and opportunities--part II. J Vasc Interv Radiol. 2001 Oct;12(10):1135-48. doi: 10.1016/s1051-0443(07)61670-4. No abstract available.
- Background: PubMed 11895200Wood BJ. Feasibility of thermal ablation of lytic vertebral metastases with radiofrequency current. Cancer J. 2002 Jan-Feb;8(1):26-8; discussion 28-9. doi: 10.1097/00130404-200201000-00004. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Neoplasms, run by National Institutes of Health Clinical Center (CC) 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 13 inclusion and 5 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: finished, as of the sponsor's last update on 4 Mar 2008. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00041886, which also lists 3 linked publications.
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 4 Mar 2008.