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A Registry Study of Permanent Breast Seed Implant

22. Oktober 2021 aktualisiert von: Dr. Eric Leung, Sunnybrook Health Sciences Centre

A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.

Women found to have early stage breast cancer will have their cancer surgically removed followed by radiation treatment to the entire breast, five times per week for several weeks. The radiation treatment prevents the cancer from growing back but creates skin burns. Several studies have showed that it is nor necessary treating the whole breast.

The investigators team has pioneered a new therapy realizing the permanent implantation of tiny radioactive seeds into the surgical cavity in a single one hour procedure under light anesthesia. Patients live a normal life while receiving the radiation treatment. The results of a first clinical trial on 67 patients shows that the treatment is well tolerate and efficient. The purpose of the study is to offer the treatment in several places and to increase the cohort of patient to 420 to capture rare complications if any.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

For early stage breast cancer, accelerated partial breast irradiation is an alternative treatment option to whole breast irradiation after breast conserving surgery. Our group has previously reported results of a Phase I/II study of permanent breast seed implant (PBSI) using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected breast cancer patients. The procedure is realised in a single session under light sedation and local freezing. After a median FU of 54 months no patients has recurred on a cohort of 67 patients, and acute of delayed side effect compared favourably to external beam radiotherapy.

Yet this study was a single centre study and the sample size did not allow evaluating appropriately the risk of serious adverse events (SAE). The current study propose evaluating SAE on a multicentre and larger cohort of 420 patients.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

420

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M4N3M5
        • Sunnybrook Odette Cancer Centre

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  • A confirmed histological diagnosis of invasive breast carcinoma
  • Treated by breast conserving surgery with axillary node dissection (with a minimum of 6 nodes sampled) or sentinel lymph node biopsy
  • Surgical margins clear over or equal to 2 mm
  • A maximum tumor size of 3 cm
  • Age >= 50 years old
  • ECOG performance status of 0 or 1
  • Informed consent signed

Exclusion Criteria:

  • Previous history of cancer other than curable skin SCC or Tis or T1 cervix
  • Patient receiving anti-coagulant that cannot be stopped two weeks prior PBSI
  • Autoimmune disorder
  • Diabetes insulin-dependant
  • Pregnancy
  • Breast implants
  • Psychiatric or addictive disorder that would preclude attending follow-up
  • Post-operative breast infection
  • Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
  • Lobular features on histology (pure or mixed) or sarcoma histology
  • Node positive on axillary dissection or in the sentinel lymph node biopsy
  • Extensive in situ carcinoma
  • Multicentric disease (in more than one quadrant or separated by 2 cm or more)
  • Paget's disease of the nipple
  • Metastases
  • Patients presenting a post-surgical fluid cavity ≥ 2.5 cm in diameter in any dimension as determined on the planning US
  • Clear delineation of the target volume on CT is not possible
  • Having a volume to be implanted over 120cc
  • Having a target volume too close to skin such that the 85% isodose overlaps the skin surface)
  • Having a target volume too close to the chest wall, such that there is a risk of perforating the chest wall

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: PBSI
PBSI is a form of accelerated partial breast irradiation involving the insertion of 103-palladium stranded seeds under ultra-sound guidance and light sedation after CT planning in lieu of whole breast adjuvant radiotherapy.
Strahlung: Permanent breast seeds implant
Patients are pre-planned using CT simulation. Implant is realised under light sedation and local freezing. Stranded seeds are inserted using a brachytherapy template that is immobilised to the planned target volume using a 'localization' needle. Patients is released the same day and Quality Assurance involves a 2 months post-implant CT
Andere Namen:
  • Artemend

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Serious Adverse Events
Zeitfenster: Initial and then yearly up to 5 years
Serious Adverse Events (SAE) is an unintended sign, symptom, or syndrome illness that occurs during the period of observation in the clinical study and that is life threatening or result in death. SAE will be coded using the NCI CTC V3.0 scale and corresponds to grade 4 or 5 signs or symptoms.
Initial and then yearly up to 5 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Breast cancer local recurrence
Zeitfenster: Yearly up to 10 years
Ipsilateral in-breast or chest wall recurrence is defined as evidence of invasive or in situ breast cancer (except LCIS) in the ipsilateral breast. Patients will have a biopsy of the suspicious lesion to confirm the diagnosis with documentation of the location.
Yearly up to 10 years
Regional recurrence
Zeitfenster: Yearly up to 10 years
Regional recurrence is defined as the development of tumor in regional nodes as well as the soft tissue of the ipsilateral axilla after axillary dissection. The regional recurrence is suspected on imaging and/or clinical symptoms and must be documented with fine needle aspiration. Also the localisation of the nodal recurrence must be reported (internal mammary chain, supra-clavicular area or axilla).
Yearly up to 10 years
Metastases
Zeitfenster: Yearly up to 10 years
Distant recurrence is defined as evidence of tumor in any area of the body. The metastasis recurrence should be proved by appropriate imaging, biopsy or fine needle aspiration
Yearly up to 10 years
PBSI side effects
Zeitfenster: After procedure
Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
After procedure
PBSI side effects
Zeitfenster: At 2 months
Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
At 2 months
PBSI side effect
Zeitfenster: At 6 months
Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale.
At 6 months
PBSI side effect
Zeitfenster: Yearly up to 10 years
Any toxicity related to the radiation treatment, including skin and subcutaneous, or any other organ in case of seed migration will be coded using the NCI common toxicity criteria version 3.0 scale. Fat necrosis will be diagnosed either by mammography or clinically (prolonged indurations and pain in the area of seeds implantation without evidence of infection).
Yearly up to 10 years
Cosmetic outcome
Zeitfenster: Yearly up to 10 years
Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist. An excellent cosmetic result score is assigned when the treated breast looked essentially the same as the contralateral breast (as it relates to radiation effects). A good cosmetic score is assigned for minimal but identifiable radiation effects of the treated breast. A fair score means significant radiation effects were readily observable. A poor score is used for severe sequelae of breast tissue secondary to radiation effects.
Yearly up to 10 years
Survival
Zeitfenster: Yearly up to 10 years
Patient survival, either free of cancer or with disease present will be recorded at follow-up appointments.
Yearly up to 10 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sunnybrook Health Sciences Centre

Mitarbeiter

West Penn Allegheny Health System
British Columbia Cancer Agency

Ermittler

  • Studienstuhl: Eric Leung, MD, Sunnybrook Health Sciences Centre

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2009

Primärer Abschluss (Tatsächlich)

19. Januar 2018

Studienabschluss (Tatsächlich)

19. Januar 2018

Studienanmeldedaten

Zuerst eingereicht

9. April 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. April 2010

Zuerst gepostet (Schätzen)

20. April 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Oktober 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Oktober 2021

Zuletzt verifiziert

1. Oktober 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PBSI Registry

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