A Phase 1/2 interventional study of AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe) in Cancer of the Breast, sponsored by University of Arkansas. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-24.
Sponsored by University of Arkansas · Phase 1/2, Interventional, and Treatment
In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.
While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (\< 3 mm) which occurs on average in \~40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 107 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is a non-randomized one arm study, all subjects receive treatment (radiofrequency ablation).
Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)
Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
Number of Patients Requiring 2nd Surgery for Close or Positive Margins
A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.
Time frame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery
Recurrence of Breast Cancer at Prior Site of Disease
Time frame: Until study end (2 years)
The first subject was consented to the study in September 2004. The final subject was consented in March 2010. A total of 107 subjects were consented.
| Milestone | Subjects Received RFA Treatment |
|---|---|
| Started | 107 |
| Completed | 100 |
| Not completed | 7 |
A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.
| participants | Margin Status |
|---|---|
| Number of Patients Requiring 2nd Surgery for Close or Positive Margins | 22 |
| participants | Recurrences at the Site |
|---|---|
| Recurrence of Breast Cancer at Prior Site of Disease | 2 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RFA Treatment | — | 0/107 (0%) | 9/107 (8.4%) |
| Event | RFA Treatment |
|---|---|
| Wound complicationSkin and subcutaneous tissue disorders | 9/107 |
| Age, Continuous(years) | RFA Treatment |
|---|---|
| Mean | 65.02 ± 10 |
| Sex: Female, Male(Participants) | RFA Treatment |
|---|---|
| Female | 107 |
| Male | 0 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Arkansas