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Radiofrequency Ablation in Treating Patients With Early Invasive Breast Cancer or Ductal Carcinoma in Situ

25. marts 2010 opdateret af: University of California, Davis

A Pilot Study of Radiofrequency Ablation of Early Invasive and In Situ Breast Cancer

RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving radiofrequency ablation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying how well radiofrequency ablation followed by surgery works in treating patients with early invasive breast cancer or ductal carcinoma in situ.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the effectiveness of radiofrequency ablation (RFA), in terms of amount of tumor coagulated and viable cell count, in patients with early invasive breast cancer or low- or intermediate-grade ductal carcinoma in situ.

Secondary

  • Determine the size, configuration, and pathological features of human breast tumors after treatment with RFA.
  • Determine whether RFA energy applied to breast cancer will result in cancer cell death.
  • Determine whether tumor-free margins are achieved by RFA in these patients.
  • Determine the rate of acute toxicities to skin after surgery in patients treated with this regimen.

OUTLINE: This is a pilot study.

  • Pre-radiofrequency ablation (RFA) procedures: Patients undergo staging by MRI assessment to determine the size of their tumor. Patients with nonpalpable lesions must undergo placement of a metallic clip in the center of their tumor and a hook wire to guide surgical excision by intraoperative ultrasound imaging. Patients with invasive breast cancer undergo axillary lymph node dissection or sentinel lymph node biopsy (SLNB) for axillary lymph node staging. Patients with ductal carcinoma in situ proceed directly to RFA/resection since they do not require axillary staging.
  • RFA: Patients undergo RFA comprising insertion of a multiple-needle electrode into the breast tumor under direct guidance of ultrasonography and the metallic clip placed preoperatively in the lesion.
  • Surgical resection of RFA area: After RFA is completed, the electrode is removed and patients undergo wide local excision of the residual tumor or mastectomy.

After completion of study therapy, patients are followed periodically for up to 4 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Females of ages ≥18 years.
  • Core biopsy proven invasive breast cancer OR
  • Core biopsy proven low or intermediate grade DCIS.
  • Tumor less than or equal to 2.0 cm in diameter.
  • No prior surgical treatment for breast cancer within 30 days.
  • Life expectancy of > 10 years, not including the diagnosis of cancer.
  • ECOG performance status of 0-2.
  • Informed consent given.
  • Multifocal invasive breast cancer patients are eligible. All tumors that are palpable or visualized by USS can be treated.

Exclusion Criteria:

  • Male subjects.
  • Ages < 18 years.
  • Breast tumor > 2.0 cm in diameter.
  • Evidence of distant metastatic disease.
  • Evidence of diffuse calcification suggestive of extensive or multifocal DCIS.
  • High grade DCIS or presence of comedo-necrosis because these lesions can be associated with invasive breast cancer, which would go undetected if the lesion is entirely destroyed by the RF ablation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: RFA prior to surgery
Procedure: conventional surgery
Standard of care lumpectomy or mastectomy following RFA
Procedure: neoadjuvant therapy
Standard of care lumpectomy or mastectomy following RFA
Procedure: radiofrequency ablation
A small diameter needle is inserted through the skin and directly into the tumor for the purpose of supplying RF current. Initial power of the RF generator will start at 5-10 watts. The power will increase by 5-10 watts every minute until impedance of the system automatically stops the RF treatment.
Andre navne:
  • RFA

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number and proportion of patients with viable cancer cells remaining in the resected specimen as measured by enzyme cell viability analysis and amount of tumor coagulated at post-treatment biopsy
Tidsramme: At completion of study
At completion of study

Sekundære resultatmål

Resultatmål
Tidsramme
Number and proportion of patients with uncoagulated tumor remnant at post-treatment biopsy
Tidsramme: At completion of study
At completion of study
Number and proportion of patients with and without tumor in the margin
Tidsramme: At completion of study
At completion of study
Rate of acute skin toxicity
Tidsramme: At completion of study
At completion of study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Davis

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Vijay Khatri, MD, University of California, Davis

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2001

Primær færdiggørelse (Faktiske)

1. maj 2007

Studieafslutning (Faktiske)

1. maj 2007

Datoer for studieregistrering

Først indsendt

12. oktober 2006

Først indsendt, der opfyldte QC-kriterier

12. oktober 2006

Først opslået (Skøn)

13. oktober 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. marts 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. marts 2010

Sidst verificeret

1. marts 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000505536
  • P30CA093373 (U.S. NIH-bevilling/kontrakt)
  • UCD-123 (Anden identifikator: University of California, Davis - Cancer Center)
  • UCD-200210277-6 (Anden identifikator: University of California, Davis - IRB)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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